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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (CM+TAU) Contingency Management + Treatment as Usual | Experimental | 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. |
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| (NC+TAU) No Contingency + Treatment as Usual | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contingency Management | Behavioral | Incentives for submitting negative-alcohol urine samples |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | Contact | 509-638-2376 | wsu.appl@wsu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sterling M McPherson, PhD | Washington State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington State University | Recruiting | Spokane | Washington | 99202 | United States |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Phase II randomized trial
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| Non-contingent control | Behavioral | Incentives for submitting urine samples |
|
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 |