Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington State University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Contingency Management
BehavioralIncentives for submitting negative-alcohol urine samples
Non-contingent control
BehavioralIncentives for submitting urine samples
Treatment groups
205 Participants
are divided into 2 treatment groupsGroup A: (CM+TAU) Contingency Management + Treatment as UsualExperimental treatment 1 intervention
Group B: (NC+TAU) No Contingency + Treatment as UsualActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
12-week treatment period and 7-month follow-up period2
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).
Time frame
12-week treatment period and 7-month follow-up periodSecondary outcomes
1
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).
Time frame
12-week treatment period and 7-month follow-up period2
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).
Time frame
12-week treatment period and 7-month follow-up periodSponsors and contacts
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Source ClinicalTrials.gov