Alcohol Use Disorder (AUD), Nicotine Use Disorder
Conditions
Keywords
Alcohol Use Disorder, Contingency Management, Incentives for Sobriety, Varenicline, Nicotine Use Disorder
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.
Interventions
BEHAVIORALContingency Management
Incentives for submitting negative-alcohol urine samples
BEHAVIORALNon-contingent control
Incentives for submitting urine samples
Sponsors
Washington State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
Phase II randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Biochemically Verified Alcohol Use | 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). |
| Change in Biochemically Verified Tobacco Use | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Self Reported Alcohol Use | 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). |
| Change in Self Reported Tobacco Use | 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). |
Countries
United States
Contacts
CONTACTResearch Coordinator
PRINCIPAL_INVESTIGATORSterling M McPherson, PhD
Washington State University
Outcome results
None listed