Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking

NCT05181891 | Recruiting Phase 2 DMC

• 1 other identifier: 18668-001
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder (AUD); Nicotine Use Disorder

Keywords

Alcohol Use Disorder; Contingency Management; Incentives for Sobriety; Varenicline; Nicotine Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Self Reported Alcohol Use

  12-week treatment period and 7-month follow-up period

• Change in Self Reported Tobacco Use

  12-week treatment period and 7-month follow-up period

Study Arms (2)

(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.

Behavioral: Contingency Management

(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.

Behavioral: Non-contingent control

Interventions

Contingency Management BEHAVIORAL

Incentives for submitting negative-alcohol urine samples

(CM+TAU) Contingency Management + Treatment as Usual

Non-contingent control BEHAVIORAL

Incentives for submitting urine samples

(NC+TAU) No Contingency + Treatment as Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington State University: lead

Study Sites (1)

Washington State University

Spokane, Washington, 99202, United States

RECRUITING

MeSH Terms

Conditions

Alcoholism; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Sterling M McPherson, PhD

  Washington State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abigail Bowen, MS

CONTACT

(425) 736-1354; abigail.bowen@wsu.edu

Sterling McPherson, PhD

CONTACT

(509) 324-7459; smcpherson05@wsu.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase II randomized trial

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 6, 2022
• Study Start: July 11, 2022
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 25, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)