Menu
Recruiting NCT05181891

Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Phase II Interventional Alcohol Use Disorder (AUD) Nicotine Use Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Contingency Management, Non-contingent control.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder (AUD), Nicotine Use Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

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.

Interventions

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

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • Change in Self Reported Alcohol Use [Time frame: 12-week treatment period and 7-month follow-up period]
  • Change in Self Reported Tobacco Use [Time frame: 12-week treatment period and 7-month follow-up period]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Washington State University — Spokane

Identifiers

NCT: NCT05181891 · 18668-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗