drugset / Trial / NCT02698215
Combining Varenicline and Naltrexone for Smoking Cessation
Phase 2
Completed
165 enrolled
University of California, Los Angeles
National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is a double-blind, randomized clinical trial using a two group medication design consisting of the combination of VAR (1 mg twice daily) + NTX (50 mg once daily) and VAR (1 mg twice daily) + PLA (matched to NTX), for smoking cessation in a sample of heavy drinking daily smokers who want to quit smoking and reduce drinking.
Timeline
- Start
- 2016-05
- Primary completion
- 2019-12
- Completion
- 2019-12
Outcome
Missed primary endpoint
paper Smoking abstinence at week 26 was significantly higher in the varenicline plus placebo condition than in the varenicline plus naltrexone condition PMID 34080890 ↗
paper although it did not meet the significance threshold. PMID 34080890 ↗
Publications
- Green R, Montoya AK, Ray LA. The relationship between drinking and smoking in a clinical trial for smoking cessation and drinking reduction. Exp Clin Psychopharmacol. 2022 Dec;30(6):873-883. doi: 10.1037/pha0000536. Epub 2021 Dec 30.
- Ray LA, Green R, Enders C, Leventhal AM, Grodin EN, Li G, Lim A, Hartwell E, Venegas A, Meredith L, Nieto SJ, Shoptaw S, Ho D, Miotto K. Efficacy of Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction: A Randomized Clinical Trial. Am J Psychiatry. 2021 Sep 1;178(9):818-828. doi: 10.1176/appi.ajp.2020.20070993. Epub 2021 Jun 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 50 mg | — |
| Comparator | Varenicline | Small molecule | 1 mg | — |