Recruiting

Alcohol & Marijuana

Sponsor:

University of Washington

Code:

NCT06736444

Conditions

Insomnia

Alcohol Use

Marijuana Use

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Interventions

Brief Behavioral Therapy for Insomnia (BBTI)

Brief Alcohol Screening and Intervention for College Students (BASICS)

Attention Control

Study Details

Brief summary:

This study is designed to evaluate an integrated intervention to reduce alcohol and marijuana use and consequences and improve sleep among young adults with comorbid heavy episodic drinking, marijuana use, and sleep impairment.

Conditions

Insomnia

Alcohol Use

Marijuana Use

Study ID

NCT06736444

Start date

Jul 2, 2025

Status verified date

Apr, 2026

Completion date

Apr 1, 2029

Anticipated

Primary completion date

Apr 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 29

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participants must: 1) be 18-29 years old; 2) reside in Washington State; 3) have valid email address; 4) score on the Insomnia Severity Index (ISI) of 10 or higher, indicating at least a moderate score (score of 2 or more) on one or more of the first three items of the ISI measuring difficulty falling asleep, staying asleep, or waking up too early; 5a) report at least two heavy drinking episodes (4+ drinks for women /gender diverse, 5+ for men in a 2-hour period) in the past month; or 5b) 1 heavy drinking occasion and at least 4 total drinking occasions in the past month; 6) have used cannabis 4+ times in the past month; and 7) did not participate in the R34 pilot feasibility trial on which the current RCT is based.

Exclusion Criteria:

  • Participants that don't meet inclusion criteria and/or failure to consent to further participation.

Study Design

Enrollment

800 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: BASICSSLEEP

The BASICSSLEEP intervention will integrate BASICS feedback and the Motivational Interviewing (MI) process described in the BASICS arm with Brief Behavioral Therapy for Insomnia (BBTI) content and materials. The BASICS + SLEEP intervention will be implemented in 2 sessions of 45-75 minutes and 2 telephone booster sessions. The investigators will follow BBTI procedures, including provision of a physiological rationale for insomnia and the importance of behavioral strategies to regulate sleep; introduction of sleep hygiene; discussion of factors that can impede duration and quality of sleep; introduction of sleep restriction and stimulus control strategies and negotiation of an initial sleep restriction schedule; and follow-up evaluation of success and continued refinement to achieve sleep efficiency goals. Booster contacts serve as opportunities to adjust the sleep restriction schedule, problem-solve challenges, and further build motivation.

active comparator: BASICS+

The BASICS+ condition will meet for 2 sessions of 45-75 minutes. Content depends on the degree to which participants discuss the feedback, have questions, and/or explore behavior change options. Therapists review feedback components with participants, eliciting personally relevant reasons to change as domains are explored. When the participant is ambivalent about change, therapists work with them to explore and resolve that ambivalence. The method is non-confrontational and utilizes exploration of personalized graphic feedback (i.e., frequency, quantity, and peak use alongside perceived and actual norms for alcohol/MJ use) to increase motivation for change by highlighting ways alcohol and/or marijuana use could be incongruent with goals or values. Beliefs, expectations, and motives for use are discussed as are strategies to minimize risks and consequences. Booster sessions address questions and problem-solve challenges that have arisen since the session.

active comparator: SLEEP

The SLEEP intervention will be implemented in 2 sessions of 45-75 minutes and 2 telephone booster sessions. The investigators will follow BBTI procedures, including provision of a physiological rationale for insomnia and the importance of behavioral strategies to regulate sleep; introduction of sleep hygiene; discussion of factors that can impede duration and quality of sleep; introduction of sleep restriction and stimulus control strategies and negotiation of an initial sleep restriction schedule; and follow-up evaluation of success and continued refinement to achieve sleep efficiency goals.

other: Attention Control

Attention Control (AC) participants complete all assessments (survey, daily, Fitbit, BAC) yoked to participants in the 3 active interventions, and attend the Zoom training to verify identity, orient to the Fitbit \& BAC monitoring, and provide rationale and instructions for daily diaries. To better control for time and attention, AC participants attend 4 weekly Zoom check-ins (\~20 minutes) in which clinically trained staff inquire about challenges encountered in monitoring, observations from monitoring, check in on mood/functioning, and provide referrals as needed. All conditions including AC receive community referrals to address substance uses, sleep, and mental health concerns. No participant is deprived of services; service use is tracked to assist with interpreting outcomes. AC participants will be offered BASICSSLEEP after completing 18-month follow-up.

Interventions

Brief Behavioral Therapy for Insomnia (BBTI)

Brief Behavioral Therapy for Insomnia (BBTI) focuses primarily on stimulus control and sleep restriction as well as sleep hygiene recommendations delivered over 2 in-person sessions and 2 brief telephone boosters and is designed to be implemented by nonspecialists in primary care or other non-clinical settings. The intervention is manualized, and clients utilize sleep diaries and workbook assignments to consolidate recommendations.

Brief Alcohol Screening and Intervention for College Students (BASICS)

Brief Alcohol Screening and Intervention for College Students (BASICS) is a manualized brief intervention targeting alcohol use and consequences among high risk drinkers and includes both personalized feedback regarding drinking norms, consequences, and motives for drinking, as well as protective behavioral skills for reducing heavy episodic drinking and related consequences. BASICS is delivered in a motivational interviewing (MI) style (Miller \& Rollnick, 2002) to enhance intrinsic motivation to change drinking and implement protective behavioral strategies. BASICS has been adapted to target marijuana use and has been adapted for use with a variety of populations.

Attention Control

Attention Control is comprised of 4 weekly 20-minute check-ins with a study therapists regarding the daily monitoring and mood/functioning. Referrals for additional services will be provided as needed.

Primary outcome measure

  • Insomnia Severity Index (ISI) [ Time Frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline) ]
  • Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI) [ Time Frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline) ]
  • Quantity/Frequency/Peak Alcohol Use Index (QFP) peak item [ Time Frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline) ]
  • Quantity/Frequency/Peak Alcohol Use Index (QFP) quantity item [ Time Frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline) ]
  • Quantity/Frequency/Peak Alcohol Use Index (QFP) frequency item [ Time Frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline) ]
  • Daily Drinking Questionnaire (DDQ) [ Time Frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline) ]
  • Rutgers Alcohol Problems Index [ Time Frame: Baseline, Post-Intervention (7 weeks post-Baseline), 3 Month Follow-up (3 months post-Baseline), 6 Month Follow-up (6 months post-Baseline), 12 Month Follow-up (12 months post-Baseline), 18 Month Follow-up (18 months post-Baseline) ]

Central Contacts and Locations

Central contacts

Mary E Larimer, Ph.D.

206-543-3513larimer@uw.edu

Nicole Fossos-Wong, B.S.

206-685-1499njf2@uw.edu

Locations

University of Washington

Recruiting

Seattle, Washington, United States, 98195

Contacts

Rosemary Whitright

206-221-3640rwhit@uw.edu

Principal Investigator:

Mary E Larimer, Ph.D.

More Information

Sponsor

University of Washington

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • Insomnia
  • Alcohol Use
  • Marijuana Use
  • Young Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Washington on 2026-04-14.