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Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young … (NCT06736444) | Clinical Trial Compass

RecruitingNot Applicable

Brief Interventions to Reduce Comorbid Alcohol and Cannabis Misuse and Sleep Impairment in Young Adults (Rest-Up RCT)

United States800 participantsStarted 2025-07-02

Plain-language 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.

Who can participate

Age range18 Years – 29 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

1

Insomnia Severity Index (ISI)

Timeframe: 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)

2

Patient-Reported Outcomes Information System Short Form v1.0 Sleep-Related Impairment 8a (PROMIS SF8 v1.0 SRI)

Timeframe: 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)

3

Quantity/Frequency/Peak Alcohol Use Index (QFP) peak item

Timeframe: 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)

4

Quantity/Frequency/Peak Alcohol Use Index (QFP) quantity item

Timeframe: 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)

5

Quantity/Frequency/Peak Alcohol Use Index (QFP) frequency item

Timeframe: 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)

Trial details

NCT IDNCT06736444

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-01

Contact for this trial

Mary E Larimer, Ph.D.

206-543-3513 larimer@uw.edu

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