Supplemental Evidence and Data Request on Interventions for Substance Use Disorders in Adolescents: A Systematic Review, 62575-62577 [2018-26304]

Download as PDF Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices Notice of Federal Travel Regulation (FTR) Bulletin 19–02, Relocation Allowances—Taxes on Travel, Transportation, and Relocation Expenses. ACTION: The purpose of this notice is to inform Federal agencies that FTR Bulletin 19–02, pertaining to travel, transportation, and relocation allowances impacted by recent changes to Federal tax law, has been published and is now available online at www.gsa.gov/ftrbulletin. DATES: Applicability: This notice applies to travel, transportation, and relocation expenses paid on or after January 1, 2018. SUMMARY: For clarification of content, please contact Mr. Rick Miller, Office of Governmentwide Policy, Office of Asset and Transportation Management, at 202– 501–3822, or by email at travelpolicy@ gsa.gov. Please cite Notice of FTR Bulletin 19–02. FOR FURTHER INFORMATION CONTACT: Dated: November 27, 2018. Jessica Salmoiraghi, Associate Administrator, Office of Government-wide Policy. [FR Doc. 2018–26342 Filed 12–3–18; 8:45 am] BILLING CODE 6820–14–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Supplemental Evidence and Data Request on Interventions for Substance Use Disorders in Adolescents: A Systematic Review Agency for Healthcare Research and Quality (AHRQ), HHS. ACTION: Request for supplemental evidence and data submissions. AGENCY: The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review of Interventions for Substance Use Disorders in Adolescents: A Systematic Review, which is currently being conducted by the AHRQ’s Evidencebased Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review. DATES: Submission Deadline on or before January 3, 2019. ADDRESSES: Email submissions: epc@ ahrq.hhs.gov. Print submissions: SUMMARY: VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 Mailing Address: Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857. Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice Improvement, Agency for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD 20857. FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301–427–1496 or Email: epc@ahrq.hhs.gov. SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for Interventions for Substance Use Disorders in Adolescents: A Systematic Review. AHRQ is conducting this systematic review pursuant to Section 902(a) of the Public Health Service Act, 42 U.S.C. 299a(a). The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (e.g., details of studies conducted). We are looking for studies that report on Interventions for Substance Use Disorders in Adolescents: A Systematic Review, including those that describe adverse events. The entire research protocol, including the key questions, is also available online at: https:// effectivehealthcare.ahrq.gov/topics/ substance-use-disorders-adolescents/ protocol. This is to notify the public that the EPC Program would find the following information on Interventions for Substance Use Disorders in Adolescents: A Systematic Review helpful: D A list of completed studies that your organization has sponsored for this indication. In the list, please indicate whether results are available on ClinicalTrials.gov along with the ClinicalTrials.gov trial number. D For completed studies that do not have results on ClinicalTrials.gov, please provide a summary, including the following elements: study number, study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, primary and secondary outcomes, baseline characteristics, number of patients screened/eligible/ PO 00000 Frm 00016 Fmt 4703 Sfmt 4703 62575 enrolled/lost to follow-up/withdrawn/ analyzed, effectiveness/efficacy, and safety results. D A list of ongoing studies that your organization has sponsored for this indication. In the list, please provide the ClinicalTrials.gov trial number or, if the trial is not registered, the protocol for the study including a study number, the study period, design, methodology, indication and diagnosis, proper use instructions, inclusion and exclusion criteria, and primary and secondary outcomes. D Description of whether the above studies constitute ALL Phase II and above clinical trials sponsored by your organization for this indication and an index outlining the relevant information in each submitted file. Your contribution will be very beneficial to the EPC Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on indications not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter. The draft of this review will be posted on AHRQ’s EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at: https:// www.effectivehealthcare.ahrq.gov/ email-updates. The systematic review will answer the following questions. This information is provided as background. AHRQ is not requesting that the public provide answers to these questions. The Key Questions KQ 1: What are the effects of behavioral, pharmacologic, and combined interventions compared with placebo or no active treatment for substance use disorders and problematic substance use 1 in adolescents to achieve abstinence, reduce quantity and frequency of use, improve functional outcomes, and reduce substance-related harms? a. How do benefits and adverse outcomes of interventions vary by subpopulations? 2 1 Substances considered: Alcohol, cannabis, opioids, sedatives/hypnotics/anxiolytics, stimulants, inhalants and hallucinogens. Tobacco is excluded. 2 Subpopulations considered: Psychiatric comorbidities, age (early, middle and late E:\FR\FM\04DEN1.SGM Continued 04DEN1 62576 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices b. How do benefits and adverse outcomes of interventions vary by intervention characteristics? 3 KQ 2: What are the comparative effects of active interventions for substance use disorders and problematic substance use 1 in adolescents to achieve abstinence, reduce quantity and frequency of use, improve functional outcomes, and reduce harms? a. How do comparative benefits and adverse outcomes of interventions vary by subpopulations? 2 b. How do comparative benefits and adverse outcomes of interventions vary by intervention characteristics? 3 PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, Settings) Population (all KQs) • Age: Adolescents (12–20 years inclusive) Æ Exclude if >20 percent of study sample (or identifiable subgroup) is <12 or >20 years, combined • SUD or problematic use of: Æ Alcohol D Exclude primary studies of treatment of alcohol use disorder/ problematic alcohol use in the college setting (we will include existing systematic reviews) Æ Cannabis Æ Opioids D Nonmedical prescription drug use (codeine, hydrocodone, oxycodone) D Illicit (e.g., heroin, illicit synthetics) Æ Sedatives, hypnotics, or anxiolytics (e.g., benzodiazepines, carbamates, barbiturates, methaqualone) Æ Stimulants D Nonmedical prescription drug use (e.g., methylphenidate) D Illicit (e.g., cocaine, methamphetamine) Æ Inhalants Æ Hallucinogens (e.g., phencyclidine, ketamine, MDMA, LSD) Æ Unspecified or polysubstance use D Exclude if predominately tobacco/ nicotine use Æ Exclude tobacco/nicotine use disorder or problematic tobacco/ nicotine use Æ Exclude limited (or experimental) substance use that has not been deemed to be at least ‘‘problematic’’ • Subpopulations of interest (not necessary for eligibility) Æ Psychiatric comorbidities adolescence), sex and gender, race/ethnicity, socioeconomic status and related characteristics (e.g., homelessness, poverty), pregnant, postpartum, and parenting adolescents, demographic/family characteristics. Factors in bold will be prioritized if necessary. 3 Intervention characteristics: Target (e.g. teen, family or group of teens), duration and setting. VerDate Sep<11>2014 17:36 Dec 03, 2018 Jkt 247001 D Attention deficit hyperactivity disorder (ADHD), depression, other internalizing and externalizing disorders. Æ Age D Early adolescence (12–14 years) D Middle adolescence (15–17 years) D Late adolescence (18–20 years) Æ Sex and gender D Male vs. female D Gender identity (cis vs. transgender) D Sexual orientation Æ Racial/ethnic minority Æ Socioeconomic status and related characteristics (e.g., homelessness, poverty) Æ Pregnant, postpartum, and parenting adolescents Æ Demographic/family characteristics D Demographics D Family and community dynamics (i.e. substance using family member) D Involvement with child protection services. Interventions • Behavioral health treatments (major intervention models are indicated by arrowhead bullets, in bold) ➢ Family Therapies Æ Family behavioral therapy (FBT) Æ Family systems therapy (FST) D Brief strategic family therapy (BSFT) Æ Functional family therapy (FFT) Æ Ecological family therapy Æ Multidimensional family therapy (MDFT) Æ Ecologically based family therapy (EBFT) Æ Family systems network (FSN) Æ Educational family therapy Æ Multi-systemic therapy (MST) ➢ Cognitive Behavioral Therapy (CBT) Æ Adolescent community reinforcement approach (ACRA) Æ Dialectical behavior therapy Æ Cognitive therapy ➢ Contingency Management ➢ Motivational Interviewing/ Motivation Enhancement Therapy ➢ Multi-Component Interventions consisting of two or more models (e.g., MST + CBT; FFT + CBT) ➢ Psychoeducation ➢ Treatment as Usual (does not meet criteria for any of the above categories) ➢ Integrated Interventions for substance use and a co-occurring disorder ➢ Other Æ Culturally sensitive interventions ➢ Recovery Support Æ 12-step programs PO 00000 Frm 00017 Fmt 4703 Sfmt 4703 Æ Peer-based and/or peer supports Æ Assertive continuing care (ACC) Exclude primary (universal) and secondary preventive interventions. Exclude interventions used in population that do not aim to reduce substance use (e.g., needle exchange). • Pharmacologic Interventions D Exclude medications being used to treat overdose (e.g., naloxone) D Exclude pharmacologic management of acute withdrawal symptoms Æ Medications to reduce and/or eliminate substance use and to prevent relapse (See Appendix B for details of FDA approvals) D Alcohol • Gabapentin • Naltrexone • Acamprosate • Disulfiram • Topiramate • Ondansetron D Cannabis • N-acetylcysteine (NAC) D Opioids • Methadone • Buprenorphine • Buprenorphine/Naloxone • Naltrexone Æ Medications to treat co-occurring psychiatric disorders in patients in patients with concurrent problematic substance use or SUD. Comparators KQ 1 • No active treatment Æ Wait list Æ Placebo (for medications) • Usual care (if not a clearly defined behavioral intervention) KQ 2 • Active interventions (we will evaluate other comparisons if the evidence allows) Æ Pharmacologic plus behavioral vs. behavioral or pharmacologic alone Æ Between major behavioral intervention models (e.g. family therapy, cognitive behavioral therapy) Æ Multicomponent interventions vs. single behavioral intervention model Outcomes ➢ Abstinence Æ Urine drug test results (from substance identified on admission to treatment, abstinence from all substances, duration of abstinence) ➢ Quantity, Frequency, or Severity of Use (of primary substance identified on entry to treatment and other substances) Æ Days of use/abstinence over E:\FR\FM\04DEN1.SGM 04DEN1 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices specified time period Æ Quantity of use over specified time period Æ Substance-related problems/ symptom count scales ➢ Functional Outcomes Exclusions Æ School performance and educational attainment D Attendance D Grades/academic performance D Graduation rates D Entering higher education (including trade schools) Æ Social relationships D Family functioning D Peer relationships Æ Case-control studies Æ Cross-sectional studies Æ Single-arm studies of behavioral interventions Æ Conference abstracts letters, and other non-peer reviewed reports Timing ➢ Harmful Consequences Associated With SUD Æ D Æ • D D D D • D D D Æ • • • Mental health outcomes Suicidal ideation and behavior Physical health outcomes Mortality All-cause Drug-related, including fatal overdose Morbidity Injuries (non-fatal) Infections HIV Hepatitis C Other sexually transmitted infections Legal outcomes Arrests Drunk or impaired driving Contact with juvenile justice system ➢ Adverse Effects of Intervention(s) Francis D. Chesley, Jr., Acting Deputy Director. [FR Doc. 2018–26304 Filed 12–3–18; 8:45 am] BILLING CODE 4160–90–P National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: NIOSH announces the availability of the final National Occupational Research Agenda for Oil and Gas Extraction DATES: The final document was published on November 27, 2018 on the CDC website. ADDRESSES: The document may be obtained at the following link: https:// www.cdc.gov/nora/councils/oilgas/ agenda.html SUMMARY: Frm 00018 Emily Novicki, M.A., M.P.H, (NORACoordinator@cdc.gov), National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention, Mailstop E–20, 1600 Clifton Road NE, Atlanta, GA 30329, phone (404) 498–2581 (not a toll free number). SUPPLEMENTARY INFORMATION: On July 26, 2018, NIOSH published a request for public review in the Federal Register [83 FR 35485] of the draft version of the National Occupational Research Agenda for Oil and Gas Extraction. The single comment received expressed support. Dated: November 29, 2018. Frank J. Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. Fmt 4703 BILLING CODE 4163–19–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–6063–N4] Medicare Program; Extension of Prior Authorization for Repetitive Scheduled Non-Emergent Ambulance Transports Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: Final National Occupational Research Agenda for Oil and Gas Extraction PO 00000 FOR FURTHER INFORMATION CONTACT: [FR Doc. 2018–26315 Filed 12–3–18; 8:45 am] • Any setting, including (but not limited to) primary care, school, outpatient, emergency department, in-patient, intensive outpatient, partial hospitalization, intensive inpatient/residential, juvenile justice Exclude: laboratory-based assessments. [CDC–2018–0065; Docket Number NIOSH– 317] • Published, peer reviewed articles and data from clinicaltrials.gov Æ Randomized controlled trials (including cross-over trials) D N ≥ 10 participants per study group Æ Large nonrandomized comparative studies with longitudinal follow-up D N ≥ 100 participants per study group D Must report multiple regression, other adjustment, matching, propensity scoring, or other method to account for confounding. Æ Single arm pharmacologic studies with at least 200 participants and longitudinal follow-up (to identify side-effects of medications) Æ We will summarize information from existing systematic reviews Jkt 247001 Setting Centers for Disease Control and Prevention Study Designs and Information Sources 17:36 Dec 03, 2018 • Any duration of treatment • Duration of follow-up of at least a month (but must be longitudinal with separation in time between intervention and outcomes) DEPARTMENT OF HEALTH AND HUMAN SERVICES Æ Side effects of pharmacologic interventions Æ Loss of privacy/confidentiality Æ Stigmatization/discrimination Æ Iatrogenic effects of group therapy due to peer deviance Æ Other reported adverse effects ascribed to interventions VerDate Sep<11>2014 specific to treatment of alcohol SUD on college campuses D SR eligible if inclusion criteria for individual studies consistent with our PICOTS criteria for individual studies. 62577 Sfmt 4703 This notice announces a 1year extension of the Medicare Prior Authorization Model for Repetitive Scheduled Non-Emergent Ambulance Transport. The extension of this model is applicable to the following states and the District of Columbia: Delaware, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia. DATES: This extension begins on December 2, 2018 and ends on December 1, 2019. FOR FURTHER INFORMATION CONTACT: Angela Gaston, (410) 786–7409. Questions regarding the Medicare Prior Authorization Model Extension for Repetitive Scheduled Non-Emergent Ambulance Transport should be sent to AmbulancePA@cms.hhs.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background Medicare may cover ambulance services, including air ambulance (fixed-wing and rotary-wing) services, if the ambulance service is furnished to a beneficiary whose medical condition is E:\FR\FM\04DEN1.SGM 04DEN1

Agencies

[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62575-62577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-26304]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Agency for Healthcare Research and Quality


Supplemental Evidence and Data Request on Interventions for 
Substance Use Disorders in Adolescents: A Systematic Review

AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.

ACTION: Request for supplemental evidence and data submissions.

-----------------------------------------------------------------------

SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is 
seeking scientific information submissions from the public. Scientific 
information is being solicited to inform our review of Interventions 
for Substance Use Disorders in Adolescents: A Systematic Review, which 
is currently being conducted by the AHRQ's Evidence-based Practice 
Centers (EPC) Program. Access to published and unpublished pertinent 
scientific information will improve the quality of this review.

DATES: Submission Deadline on or before January 3, 2019.

ADDRESSES: Email submissions: [email protected].
    Print submissions:
    Mailing Address: Center for Evidence and Practice Improvement, 
Agency for Healthcare Research and Quality, ATTN: EPC SEADs 
Coordinator, 5600 Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857.
    Shipping Address (FedEx, UPS, etc.): Center for Evidence and 
Practice Improvement, Agency for Healthcare Research and Quality, ATTN: 
EPC SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496 
or Email: [email protected].

SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and 
Quality has commissioned the Evidence-based Practice Centers (EPC) 
Program to complete a review of the evidence for Interventions for 
Substance Use Disorders in Adolescents: A Systematic Review. AHRQ is 
conducting this systematic review pursuant to Section 902(a) of the 
Public Health Service Act, 42 U.S.C. 299a(a).
    The EPC Program is dedicated to identifying as many studies as 
possible that are relevant to the questions for each of its reviews. In 
order to do so, we are supplementing the usual manual and electronic 
database searches of the literature by requesting information from the 
public (e.g., details of studies conducted). We are looking for studies 
that report on Interventions for Substance Use Disorders in 
Adolescents: A Systematic Review, including those that describe adverse 
events. The entire research protocol, including the key questions, is 
also available online at: https://effectivehealthcare.ahrq.gov/topics/substance-use-disorders-adolescents/protocol.
    This is to notify the public that the EPC Program would find the 
following information on Interventions for Substance Use Disorders in 
Adolescents: A Systematic Review helpful:
    [ssquf] A list of completed studies that your organization has 
sponsored for this indication. In the list, please indicate whether 
results are available on ClinicalTrials.gov along with the 
ClinicalTrials.gov trial number.
    [ssquf] For completed studies that do not have results on 
ClinicalTrials.gov, please provide a summary, including the following 
elements: study number, study period, design, methodology, indication 
and diagnosis, proper use instructions, inclusion and exclusion 
criteria, primary and secondary outcomes, baseline characteristics, 
number of patients screened/eligible/enrolled/lost to follow-up/
withdrawn/analyzed, effectiveness/efficacy, and safety results.
    [ssquf] A list of ongoing studies that your organization has 
sponsored for this indication. In the list, please provide the 
ClinicalTrials.gov trial number or, if the trial is not registered, the 
protocol for the study including a study number, the study period, 
design, methodology, indication and diagnosis, proper use instructions, 
inclusion and exclusion criteria, and primary and secondary outcomes.
    [ssquf] Description of whether the above studies constitute ALL 
Phase II and above clinical trials sponsored by your organization for 
this indication and an index outlining the relevant information in each 
submitted file.
    Your contribution will be very beneficial to the EPC Program. 
Materials submitted must be publicly available or able to be made 
public. Materials that are considered confidential; marketing 
materials; study types not included in the review; or information on 
indications not included in the review cannot be used by the EPC 
Program. This is a voluntary request for information, and all costs for 
complying with this request must be borne by the submitter.
    The draft of this review will be posted on AHRQ's EPC Program 
website and available for public comment for a period of 4 weeks. If 
you would like to be notified when the draft is posted, please sign up 
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
    The systematic review will answer the following questions. This 
information is provided as background. AHRQ is not requesting that the 
public provide answers to these questions.

The Key Questions

    KQ 1: What are the effects of behavioral, pharmacologic, and 
combined interventions compared with placebo or no active treatment for 
substance use disorders and problematic substance use \1\ in 
adolescents to achieve abstinence, reduce quantity and frequency of 
use, improve functional outcomes, and reduce substance-related harms?
---------------------------------------------------------------------------

    \1\ Substances considered: Alcohol, cannabis, opioids, 
sedatives/hypnotics/anxiolytics, stimulants, inhalants and 
hallucinogens. Tobacco is excluded.
---------------------------------------------------------------------------

    a. How do benefits and adverse outcomes of interventions vary by 
subpopulations? \2\
---------------------------------------------------------------------------

    \2\ Subpopulations considered: Psychiatric co-morbidities, age 
(early, middle and late adolescence), sex and gender, race/
ethnicity, socioeconomic status and related characteristics (e.g., 
homelessness, poverty), pregnant, postpartum, and parenting 
adolescents, demographic/family characteristics. Factors in bold 
will be prioritized if necessary.

---------------------------------------------------------------------------

[[Page 62576]]

    b. How do benefits and adverse outcomes of interventions vary by 
intervention characteristics? \3\
---------------------------------------------------------------------------

    \3\ Intervention characteristics: Target (e.g. teen, family or 
group of teens), duration and setting.
---------------------------------------------------------------------------

    KQ 2: What are the comparative effects of active interventions for 
substance use disorders and problematic substance use \1\ in 
adolescents to achieve abstinence, reduce quantity and frequency of 
use, improve functional outcomes, and reduce harms?
    a. How do comparative benefits and adverse outcomes of 
interventions vary by subpopulations? \2\
    b. How do comparative benefits and adverse outcomes of 
interventions vary by intervention characteristics? \3\
    PICOTS (Populations, Interventions, Comparators, Outcomes, Timing, 
Settings)

Population (all KQs)

 Age: Adolescents (12-20 years inclusive)
    [cir] Exclude if >20 percent of study sample (or identifiable 
subgroup) is <12 or >20 years, combined
 SUD or problematic use of:
    [cir] Alcohol
    [ssquf] Exclude primary studies of treatment of alcohol use 
disorder/problematic alcohol use in the college setting (we will 
include existing systematic reviews)
    [cir] Cannabis
    [cir] Opioids
    [ssquf] Nonmedical prescription drug use (codeine, hydrocodone, 
oxycodone)
    [ssquf] Illicit (e.g., heroin, illicit synthetics)
    [cir] Sedatives, hypnotics, or anxiolytics (e.g., benzodiazepines, 
carbamates, barbiturates, methaqualone)
    [cir] Stimulants
    [ssquf] Nonmedical prescription drug use (e.g., methylphenidate)
    [ssquf] Illicit (e.g., cocaine, methamphetamine)
    [cir] Inhalants
    [cir] Hallucinogens (e.g., phencyclidine, ketamine, MDMA, LSD)
    [cir] Unspecified or polysubstance use
    [ssquf] Exclude if predominately tobacco/nicotine use
    [cir] Exclude tobacco/nicotine use disorder or problematic tobacco/
nicotine use
    [cir] Exclude limited (or experimental) substance use that has not 
been deemed to be at least ``problematic''
 Subpopulations of interest (not necessary for eligibility)
    [cir] Psychiatric comorbidities
    [ssquf] Attention deficit hyperactivity disorder (ADHD), 
depression, other internalizing and externalizing disorders.
    [cir] Age
    [ssquf] Early adolescence (12-14 years)
    [ssquf] Middle adolescence (15-17 years)
    [ssquf] Late adolescence (18-20 years)
    [cir] Sex and gender
    [ssquf] Male vs. female
    [ssquf] Gender identity (cis vs. transgender)
    [ssquf] Sexual orientation
    [cir] Racial/ethnic minority
    [cir] Socioeconomic status and related characteristics (e.g., 
homelessness, poverty)
    [cir] Pregnant, postpartum, and parenting adolescents
    [cir] Demographic/family characteristics
    [ssquf] Demographics
    [ssquf] Family and community dynamics (i.e. substance using family 
member)
    [ssquf] Involvement with child protection services.

Interventions

 Behavioral health treatments (major intervention models are 
indicated by arrowhead bullets, in bold)

[rtarr8] Family Therapies

    [cir] Family behavioral therapy (FBT)
    [cir] Family systems therapy (FST)
    [ssquf] Brief strategic family therapy (BSFT)
    [cir] Functional family therapy (FFT)
    [cir] Ecological family therapy
    [cir] Multidimensional family therapy (MDFT)
    [cir] Ecologically based family therapy (EBFT)
    [cir] Family systems network (FSN)
    [cir] Educational family therapy
    [cir] Multi-systemic therapy (MST)

[rtarr8] Cognitive Behavioral Therapy (CBT)

    [cir] Adolescent community reinforcement approach (ACRA)
    [cir] Dialectical behavior therapy
    [cir] Cognitive therapy

[rtarr8] Contingency Management

[rtarr8] Motivational Interviewing/Motivation Enhancement Therapy

[rtarr8] Multi-Component Interventions consisting of two or more models 
(e.g., MST + CBT; FFT + CBT)

[rtarr8] Psychoeducation

[rtarr8] Treatment as Usual (does not meet criteria for any of the 
above categories)

[rtarr8] Integrated Interventions for substance use and a co-occurring 
disorder

[rtarr8] Other

    [cir] Culturally sensitive interventions

[rtarr8] Recovery Support

    [cir] 12-step programs
    [cir] Peer-based and/or peer supports
    [cir] Assertive continuing care (ACC)
    Exclude primary (universal) and secondary preventive interventions.
    Exclude interventions used in population that do not aim to reduce 
substance use (e.g., needle exchange).

 Pharmacologic Interventions

    [ssquf] Exclude medications being used to treat overdose (e.g., 
naloxone)
    [ssquf] Exclude pharmacologic management of acute withdrawal 
symptoms
    [cir] Medications to reduce and/or eliminate substance use and to 
prevent relapse (See Appendix B for details of FDA approvals)
    [ssquf] Alcohol
     Gabapentin
     Naltrexone
     Acamprosate
     Disulfiram
     Topiramate
     Ondansetron
    [ssquf] Cannabis
     N-acetylcysteine (NAC)
    [ssquf] Opioids
     Methadone
     Buprenorphine
     Buprenorphine/Naloxone
     Naltrexone
    [cir] Medications to treat co-occurring psychiatric disorders in 
patients in patients with concurrent problematic substance use or SUD.

Comparators

KQ 1

 No active treatment
    [cir] Wait list
    [cir] Placebo (for medications)
 Usual care (if not a clearly defined behavioral intervention)

KQ 2

 Active interventions (we will evaluate other comparisons if 
the evidence allows)
    [cir] Pharmacologic plus behavioral vs. behavioral or pharmacologic 
alone
    [cir] Between major behavioral intervention models (e.g. family 
therapy, cognitive behavioral therapy)
    [cir] Multicomponent interventions vs. single behavioral 
intervention model

Outcomes

[rtarr8] Abstinence

    [cir] Urine drug test results (from substance identified on 
admission to treatment, abstinence from all substances, duration of 
abstinence)

[rtarr8] Quantity, Frequency, or Severity of Use (of primary substance 
identified on entry to treatment and other substances)

    [cir] Days of use/abstinence over

[[Page 62577]]

specified time period
    [cir] Quantity of use over specified time period
    [cir] Substance-related problems/symptom count scales

[rtarr8] Functional Outcomes

    [cir] School performance and educational attainment
    [ssquf] Attendance
    [ssquf] Grades/academic performance
    [ssquf] Graduation rates
    [ssquf] Entering higher education (including trade schools)
    [cir] Social relationships
    [ssquf] Family functioning
    [ssquf] Peer relationships

[rtarr8] Harmful Consequences Associated With SUD

    [cir] Mental health outcomes
    [ssquf] Suicidal ideation and behavior
    [cir] Physical health outcomes
     Mortality
    [ssquf] All-cause
    [ssquf] Drug-related, including fatal overdose
    [ssquf] Morbidity
    [ssquf] Injuries (non-fatal)
     Infections
    [ssquf] HIV
    [ssquf] Hepatitis C
    [ssquf] Other sexually transmitted infections
    [cir] Legal outcomes
     Arrests
     Drunk or impaired driving
     Contact with juvenile justice system

[rtarr8] Adverse Effects of Intervention(s)

[cir] Side effects of pharmacologic interventions
[cir] Loss of privacy/confidentiality
[cir] Stigmatization/discrimination
[cir] Iatrogenic effects of group therapy due to peer deviance
[cir] Other reported adverse effects ascribed to interventions

Study Designs and Information Sources

 Published, peer reviewed articles and data from 
clinicaltrials.gov
    [cir] Randomized controlled trials (including cross-over trials)
    [ssquf] N >= 10 participants per study group
    [cir] Large nonrandomized comparative studies with longitudinal 
follow-up
    [ssquf] N >= 100 participants per study group
    [ssquf] Must report multiple regression, other adjustment, 
matching, propensity scoring, or other method to account for 
confounding.
    [cir] Single arm pharmacologic studies with at least 200 
participants and longitudinal follow-up (to identify side-effects of 
medications)
    [cir] We will summarize information from existing systematic 
reviews specific to treatment of alcohol SUD on college campuses
    [ssquf] SR eligible if inclusion criteria for individual studies 
consistent with our PICOTS criteria for individual studies.

Exclusions

    [cir] Case-control studies
    [cir] Cross-sectional studies
    [cir] Single-arm studies of behavioral interventions
    [cir] Conference abstracts letters, and other non-peer reviewed 
reports

Timing

 Any duration of treatment
 Duration of follow-up of at least a month (but must be 
longitudinal with separation in time between intervention and outcomes)

Setting

 Any setting, including (but not limited to) primary care, 
school, outpatient, emergency department, in-patient, intensive 
outpatient, partial hospitalization, intensive inpatient/residential, 
juvenile justice
    Exclude: laboratory-based assessments.

Francis D. Chesley, Jr.,
Acting Deputy Director.
[FR Doc. 2018-26304 Filed 12-3-18; 8:45 am]
BILLING CODE 4160-90-P