Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Study Overview
=================
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.

Official Title
-----------------
Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

Conditions
-----------------
Alcohol Use Disorder (AUD), Nicotine Use Disorder

Intervention / Treatment
-----------------
* Behavioral: Contingency Management
* Behavioral: Non-contingent control


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Phase II randomized trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (CM+TAU) Contingency Management + Treatment as Usual<br>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<br>* Incentives for submitting negative-alcohol urine samples<br>|
| Active Comparator: (NC+TAU) No Contingency + Treatment as Usual<br>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<br>* Incentives for submitting urine samples<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12-week treatment period and 7-month follow-up period | 
| 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). | 12-week treatment period and 7-month follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 12-week treatment period and 7-month follow-up period | 
| 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). | 12-week treatment period and 7-month follow-up period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alcohol Use Disorder, Contingency Management, Incentives for Sobriety, Varenicline, Nicotine Use Disorder