Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

NCT ID: NCT05181891

Last Updated: 2024-06-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 205 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-11
• Study Completion Date: 2026-05-01

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.

Conditions

Alcohol Use Disorder (AUD); Nicotine Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

(CM+TAU) Contingency Management + Treatment as Usual

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.

Group Type: EXPERIMENTAL

Contingency Management

Intervention Type: BEHAVIORAL

Incentives for submitting negative-alcohol urine samples

(NC+TAU) No Contingency + Treatment as Usual

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.

Group Type: ACTIVE_COMPARATOR

Non-contingent control

Intervention Type: BEHAVIORAL

Incentives for submitting urine samples

Interventions

Contingency Management

Incentives for submitting negative-alcohol urine samples

Intervention Type: BEHAVIORAL

Non-contingent control

Incentives for submitting urine samples

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Washington State University

OTHER

Sponsor Role: lead

Responsible Party

Sterling McPherson

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sterling M McPherson, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington State University

Locations

Washington State University

Spokane, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Abigail Bowen, MS

Role: CONTACT

abigail.bowen@wsu.edu

(425) 736-1354

Sterling McPherson, PhD

Role: CONTACT

smcpherson05@wsu.edu

(509) 324-7459

Facility Contacts

Abigail L Bowen, MS

Role: primary

abigail.bowen@wsu.edu

425-736-1354

Serena M McPherson, BA

Role: backup

s.mcpherson@wsu.edu

(509) 590-7689

Other Identifiers

18668-001

Identifier Type: -

Identifier Source: org_study_id