NCT05181891 Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
| NCT ID | NCT05181891 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Washington State University |
| Condition | Alcohol Use Disorder (AUD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 205 participants |
| Start Date | 2022-07-11 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 205 participants in total. It began in 2022-07-11 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Sterling M McPherson, PhD
PRINCIPAL INVESTIGATOR
Washington State University
Frequently Asked Questions
Who can join the NCT05181891 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Alcohol Use Disorder (AUD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05181891 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05181891 currently recruiting?
Yes, NCT05181891 is actively recruiting participants. Contact the research team at abigail.bowen@wsu.edu for enrollment information.
Where is the NCT05181891 trial being conducted?
This trial is being conducted at Spokane, United States.
Who is sponsoring the NCT05181891 clinical trial?
NCT05181891 is sponsored by Washington State University. The principal investigator is Sterling M McPherson, PhD at Washington State University. The trial plans to enroll 205 participants.