Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Last updated: June 22, 2024
Sponsor: Washington State University
Overall Status: Active - Recruiting

Phase

2

Condition

Alcohol Use Disorder

Addictions

Alcohol Dependence

Treatment

Non-contingent control

Contingency Management

Clinical Study ID

NCT05181891
18668-001
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. 4 or more standard drinks on the same occasion for women (5 or more standard drinkson 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 lifetimecigarettes 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 inductionperiod and at least one COT-positive urine test at any time during the inductionperiod; and

  11. Attended at least 4 of 6 possible visits during the induction period.

Exclusion

Exclusion Criteria:

  1. Significant risk of dangerous alcohol withdrawal, defined as a history of alcoholdetoxification or seizure in the last 12 months and expression of concern by theparticipant 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 thatDrs. Layton or Rodin determine would compromise safe participation.

Study Design

Total Participants: 205
Treatment Group(s): 2
Primary Treatment: Non-contingent control
Phase: 2
Study Start date:
July 11, 2022
Estimated Completion Date:
May 01, 2026

Study 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.

Connect with a study center

  • Washington State University

    Spokane, Washington 99202
    United States

    Active - Recruiting

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