Recruiting
Phase 2

Pharmaceutically-Enhanced Reinforcement

Sponsor:

Washington State University

Code:

NCT05181891

Conditions

Alcohol Use Disorder (AUD)

Nicotine Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Contingency Management

Non-contingent control

Study Details

Brief summary:

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.

Conditions

Alcohol Use Disorder (AUD)

Nicotine Use Disorder

Study ID

NCT05181891

Start date

Jul 11, 2022

Status verified date

Jul, 2026

Completion date

May 1, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. 4 or more standard drinks on the same occasion for women (5 or more standard drinks on the same occasion for men) on at least 4 occasions in the prior 30 days
2. Seeking AUD treatment
3. Seeking smoking cessation treatment
4. Aged 18+ years
5. DSM-5 diagnosis of AUD
6. Currently smoking daily according to PhenX Smoking Status (100 or more lifetime cigarettes plus current daily smoking)
7. Ability to read and speak English
8. Ability to provide written informed consent
9. Breath alcohol of 0.00 during informed consent
10. Provision of at least 1 EtG-positive urine test at any time during the induction period and at least one COT-positive urine test at any time during the induction period; and
11. Attended at least 4 of 6 possible visits during the induction period.

Exclusion Criteria:

1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcohol detoxification or seizure in the last 12 months and expression of concern by the participant about dangerous withdrawal
2. Currently receiving any pharmacotherapy for alcohol
3. Currently receiving any pharmacotherapy for smoking
4. No suicide attempt in the last 20 years and
5. Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.

Study Design

Enrollment

205 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Contingency Management

Incentives for submitting negative-alcohol urine samples

Non-contingent control

Incentives for submitting urine samples

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Research Coordinator

509-638-2376wsu.appl@wsu.edu

Locations

Washington State University

Recruiting

Spokane, Washington, United States, 99202

Contacts

Research Coordinator

509-638-2376wsu.appl@wsu.edu

More Information

Sponsor

Washington State University

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Alcohol Use Disorder
  • Contingency Management
  • Incentives for Sobriety
  • Varenicline
  • Nicotine Use Disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington State University on 2026-07-06.