83 FR 62575 - Supplemental Evidence and Data Request on Interventions for Substance Use Disorders in Adolescents: A Systematic Review

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality

Federal Register Volume 83, Issue 233 (December 4, 2018)

Page Range		62575-62577
FR Document		2018-26304
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 Access to published and unpublished pertinent scientific information will improve the quality of this review.
Federal Register, Volume 83 Issue 233 (Tuesday, December 4, 2018)
[Federal Register Volume 83, Number 233 (Tuesday, December 4, 2018)]
[Notices]
[Pages 62575-62577]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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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 Access to published and unpublished pertinent 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?
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    \1\ Substances considered: Alcohol, cannabis, opioids, 
sedatives/hypnotics/anxiolytics, stimulants, inhalants and 
hallucinogens. Tobacco is excluded.
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    a. How do benefits and adverse outcomes of interventions vary by 
subpopulations? \2\
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    \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.

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[[Page 62576]]

    b. How do benefits and adverse outcomes of interventions vary by 
intervention characteristics? \3\
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    \3\ Intervention characteristics: Target (e.g. teen, family or 
group of teens), duration and setting.
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    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
62576 Federal Register / Vol. 83, No. 233 / Tuesday, December 4, 2018 / Notices

b. How do benefits and adverse D Attention deficit hyperactivity Æ Peer-based and/or peer supports
outcomes of interventions vary by disorder (ADHD), depression, other Æ Assertive continuing care (ACC)
intervention characteristics? 3 internalizing and externalizing Exclude primary (universal) and
KQ 2: What are the comparative disorders. secondary preventive interventions.
effects of active interventions for Æ Age Exclude interventions used in
substance use disorders and problematic D Early adolescence (12–14 years) population that do not aim to reduce
substance use 1 in adolescents to D Middle adolescence (15–17 years) substance use (e.g., needle exchange).
achieve abstinence, reduce quantity and D Late adolescence (18–20 years)
Æ Sex and gender • Pharmacologic Interventions
frequency of use, improve functional
D Male vs. female D Exclude medications being used to
outcomes, and reduce harms?
D Gender identity (cis vs. transgender) treat overdose (e.g., naloxone)
a. How do comparative benefits and D Sexual orientation D Exclude pharmacologic
adverse outcomes of interventions vary Æ Racial/ethnic minority management of acute withdrawal
by subpopulations? 2 Æ Socioeconomic status and related
b. How do comparative benefits and symptoms
characteristics (e.g., homelessness, Æ Medications to reduce and/or
adverse outcomes of interventions vary poverty) eliminate substance use and to
by intervention characteristics? 3 Æ Pregnant, postpartum, and prevent relapse (See Appendix B for
PICOTS (Populations, Interventions, parenting adolescents details of FDA approvals)
Comparators, Outcomes, Timing, Æ Demographic/family characteristics D Alcohol
Settings) D Demographics • Gabapentin
D Family and community dynamics • Naltrexone
Population (all KQs)
(i.e. substance using family • Acamprosate
• Age: Adolescents (12–20 years member) • Disulfiram
inclusive) D Involvement with child protection • Topiramate
Æ Exclude if >20 percent of study services. • Ondansetron
sample (or identifiable subgroup) is
Interventions D Cannabis
<12 or >20 years, combined • N-acetylcysteine (NAC)
• SUD or problematic use of: • Behavioral health treatments (major D Opioids
Æ Alcohol intervention models are indicated • Methadone
D Exclude primary studies of by arrowhead bullets, in bold) • Buprenorphine
treatment of alcohol use disorder/ • Buprenorphine/Naloxone
➢ Family Therapies • Naltrexone
problematic alcohol use in the
college setting (we will include Æ Family behavioral therapy (FBT) Æ Medications to treat co-occurring
existing systematic reviews) Æ Family systems therapy (FST) psychiatric disorders in patients in
D Brief strategic family therapy patients with concurrent
Æ Cannabis
(BSFT) problematic substance use or SUD.
Æ Opioids
Æ Functional family therapy (FFT)
D Nonmedical prescription drug use Æ Ecological family therapy Comparators
(codeine, hydrocodone, oxycodone) Æ Multidimensional family therapy
D Illicit (e.g., heroin, illicit synthetics) KQ 1
(MDFT)
Æ Sedatives, hypnotics, or anxiolytics Æ Ecologically based family therapy • No active treatment
(e.g., benzodiazepines, carbamates, (EBFT) Æ Wait list
barbiturates, methaqualone) Æ Family systems network (FSN) Æ Placebo (for medications)
Æ Stimulants Æ Educational family therapy • Usual care (if not a clearly defined
D Nonmedical prescription drug use Æ Multi-systemic therapy (MST) behavioral intervention)
(e.g., methylphenidate) KQ 2
➢ Cognitive Behavioral Therapy (CBT)
D Illicit (e.g., cocaine,
methamphetamine) Æ Adolescent community • Active interventions (we will evaluate
Æ Inhalants reinforcement approach (ACRA) other comparisons if the evidence
Æ Hallucinogens (e.g., phencyclidine, Æ Dialectical behavior therapy allows)
ketamine, MDMA, LSD) Æ Cognitive therapy Æ Pharmacologic plus behavioral vs.
Æ Unspecified or polysubstance use behavioral or pharmacologic alone
➢ Contingency Management Æ Between major behavioral
D Exclude if predominately tobacco/
nicotine use ➢ Motivational Interviewing/ intervention models (e.g. family
Æ Exclude tobacco/nicotine use Motivation Enhancement Therapy therapy, cognitive behavioral
disorder or problematic tobacco/ ➢ Multi-Component Interventions therapy)
consisting of two or more models (e.g., Æ Multicomponent interventions vs.
nicotine use
Æ Exclude limited (or experimental) MST + CBT; FFT + CBT) single behavioral intervention
substance use that has not been model
➢ Psychoeducation
deemed to be at least ‘‘problematic’’ Outcomes
• Subpopulations of interest (not ➢ Treatment as Usual (does not meet
criteria for any of the above categories) ➢ Abstinence
necessary for eligibility)
Æ Psychiatric comorbidities ➢ Integrated Interventions for Æ Urine drug test results (from
substance use and a co-occurring substance identified on admission
adolescence), sex and gender, race/ethnicity, disorder to treatment, abstinence from all
socioeconomic status and related characteristics substances, duration of abstinence)
(e.g., homelessness, poverty), pregnant, postpartum, ➢ Other
and parenting adolescents, demographic/family ➢ Quantity, Frequency, or Severity of
characteristics. Factors in bold will be prioritized if Æ Culturally sensitive interventions
Use (of primary substance identified on
necessary.
3 Intervention characteristics: Target (e.g. teen,
➢ Recovery Support entry to treatment and other substances)
family or group of teens), duration and setting. Æ 12-step programs Æ Days of use/abstinence over

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Document Created: 2018-12-04 00:42:03
Document Modified: 2018-12-04 00:42:03
Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Request for supplemental evidence and data submissions.
Dates		Submission Deadline on or before January 3, 2019.
Contact		Jenae Benns, Telephone: 301-427-1496 or Email: [email protected]
FR Citation		83 FR 62575
83 FR 62575 - Supplemental Evidence and Data Request on Interventions for Substance Use Disorders in Adolescents: A Systematic Review

DEPARTMENT OF HEALTH AND HUMAN SERVICESAgency for Healthcare Research and Quality

Federal Register Volume 83, Issue 233 (December 4, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
