Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Part of paid clinical trials in Spokane, Washington.

Sponsor
Washington State University
Study ID
NCT05181891
Phase
PHASE2
Status
Recruiting
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Conditions

  • Alcohol Use Disorder (AUD)
  • Nicotine Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Contingency Management — BEHAVIORAL
    Incentives for submitting negative-alcohol urine samples
  • Non-contingent control — BEHAVIORAL
    Incentives for submitting urine samples

Study Details

Using a randomized controlled trial (RCT), the goal of this study is to evaluate the ability of evidence based behavioral treatment (contingency management: CM) to significantly decrease alcohol use and cigarette smoking among treatment-seeking smokers with an alcohol use disorder (AUD) who have initiated pharmacotherapy (varenicline; VC) for smoking cessation.

Key Dates

Start date
Jul 11, 2022
Status verified
Jun 2024
Primary completion
May 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
205 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: (CM+TAU) Contingency Management + Treatment as Usual
    Varenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. Participants in CM+TAU will receive reinforcement for submitting urine samples that test negative for recent alcohol use.
  • Active Comparator: (NC+TAU) No Contingency + Treatment as Usual
    Varenicline (VC) will be supplied in .5 mg tablets once per week during the active treatment period. During the first week of treatment (Week 3) participants will be instructed to take .5 mg once per day for days 1-3, and 0.5 mg twice per day for days 4-7. The investigators will maintain a target dose of 1mg twice per day for the remaining active treatment period. Additionally, participants will also receive Take Control counseling via video. NC+TAU will receive reinforcement for submitting any urine sample, regardless of test results.

Primary Outcome Measure

Change in Biochemically Verified Alcohol Use [ Time Frame: 12-week treatment period and 7-month follow-up period ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Washington State UniversitySpokaneWashington99202
Abigail L Bowen, MS
[email protected]
425-736-1354
Serena M McPherson, BA
[email protected]
(509) 590-7689

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By research site
Washington State University· Spokane, WA

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