Clinical trial NCT05181891: Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
Official title: Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder (AUD)
Nicotine Use Disorder
Keywords: Alcohol Use Disorder
Contingency Management
Incentives for Sobriety
Varenicline
Nicotine Use Disorder
Lead sponsor: Washington State University
Sponsor class: OTHER
First posted: 2022-01-06
Enrollment: 205
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase II randomized trial
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Biochemically Verified Alcohol Use
timeFrame: 12-week treatment period and 7-month follow-up period
measure: Change in Biochemically Verified Tobacco Use
timeFrame: 12-week treatment period and 7-month follow-up period
Secondary outcomes:
measure: Change in Self Reported Alcohol Use
timeFrame: 12-week treatment period and 7-month follow-up period
measure: Change in Self Reported Tobacco Use
timeFrame: 12-week treatment period and 7-month follow-up period
Other outcomes:
Locations:
city: Spokane
country: United States
facility: Washington State University
state: Washington
Study officials:
affiliation: Washington State University
name: Sterling M McPherson, PhD
role: PRINCIPAL_INVESTIGATOR
References: