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NCT Number: NCT05181891

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington State University

Spokane, Washington, 99202, United States

Location status: Recruiting

Location contact

Research Coordinator

CONTACT

[email protected]

509-638-2376

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Seeking AUD treatment
  • Seeking smoking cessation treatment
  • Aged 18+ years
  • DSM-5 diagnosis of AUD
  • Currently smoking daily according to PhenX Smoking Status (100 or more lifetime cigarettes plus current daily smoking)
  • Ability to read and speak English
  • Ability to provide written informed consent
  • Breath alcohol of 0.00 during informed consent
  • 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
  • Attended at least 4 of 6 possible visits during the induction period.

Exclusion criteria

  • 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
  • Currently receiving any pharmacotherapy for alcohol
  • Currently receiving any pharmacotherapy for smoking
  • No suicide attempt in the last 20 years and
  • Any other medical (discernable by initial blood tests) or psychiatric condition that Drs. Layton or Rodin determine would compromise safe participation.

Treatment and study plan

Contingency Management

Behavioral

Incentives for submitting negative-alcohol urine samples

Non-contingent control

Behavioral

Incentives for submitting urine samples

Primary outcomes

  1. Change in Biochemically Verified Alcohol Use

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

    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).

  2. Change in Biochemically Verified Tobacco Use

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

    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).

Secondary outcomes

  1. Change in Self Reported Alcohol Use

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

    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).

  2. Change in Self Reported Tobacco Use

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Research Coordinator

CONTACT

[email protected]

509-638-2376

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Registry information

Acronym: PERRAS

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 6, 2022
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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