ClinicalTrials.gg
RecruitingNCT05181891PERRASUpdated Jul 6, 2026

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

A Phase 2 interventional study of Contingency Management and Non-contingent control in Alcohol Use Disorder (AUD) and Nicotine Use Disorder, sponsored by Washington State University. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

Sponsored by Washington State University · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2022; still recruiting 4 years 4 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
205
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

This randomized, placebo-controlled trial to determine the effectiveness of contingency management for reducing alcohol use and cigarette smoking among adults who want to quit or reduce their co-addiction. Contingency management is a powerful and cost-effective technique that has been used successfully for decades to promote abstinence from benzodiazepines, cocaine, tobacco, etc. Contingency management, and a non-contingent control condition will be used combined with varenicline (VC) and manualized counseling in the form of module videos.

02

Conditions studied

  • Alcohol Use Disorder (AUD)
  • Nicotine Use Disorder

Keywords

  • Alcohol Use Disorder
  • Contingency Management
  • Incentives for Sobriety
  • Varenicline
  • Nicotine Use Disorder
03

In context

Alcoholism

1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.

This study's planned enrollment of 205 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Washington State University is the lead sponsor of 83 studies on the registry; 16 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 4 (57%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. 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
  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

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
205 participants (estimated)

Study 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.

    Behavioral: Contingency Management

  • 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.

    Behavioral: Non-contingent control

Interventions

  • BehavioralContingency Management

    Incentives for submitting negative-alcohol urine samples

  • BehavioralNon-contingent control

    Incentives for submitting urine samples

06

What researchers measure

Primary outcomes

  1. Change in Biochemically Verified Alcohol Use

    Consumption of alcohol between participants randomized to CM+TAU vs NC+TAU assessed by alcohol EtG values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).

    Time frame: 12-week treatment period and 7-month follow-up period

  2. Change in Biochemically Verified Tobacco Use

    Consumption of tobacco between participants randomized to CM+TAU vs NC+TAU assessed by tobacco CO and COT values (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).

    Time frame: 12-week treatment period and 7-month follow-up period

Secondary outcomes

  1. Change in Self Reported Alcohol Use

    Consumption of alcohol between participants randomized to CM+TAU vs NC+TAU assessed by participant self report (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).

    Time frame: 12-week treatment period and 7-month follow-up period

  2. Change in Self Reported Tobacco Use

    Consumption of tobacco between participants randomized to CM+TAU vs NC+TAU assessed by participant self report (collected 3x weekly from weeks 1-14, and once at weeks 18, 30, 42).

    Time frame: 12-week treatment period and 7-month follow-up period

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05181891
Lead sponsor
Washington State University
Responsible party
Sterling McPherson (Professor, Washington State University) — Principal investigator
First posted
Jan 6, 2022
Start date
Jul 11, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
May 1, 2027 (estimated)
Last update
Jul 6, 2026

Study contacts

Research Coordinator
Contact
wsu.appl@wsu.edu
509-638-2376
Sterling M McPherson, PhD
principal investigator · Washington State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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