Clinical trial NCT02698215: Combining Varenicline and Naltrexone for Smoking Cessation
Official title: Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Alcohol Use Disorder
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-03-03
Enrollment: 165
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. All participants will be daily smokers (≥ 5 cig/day) who are also heavy drinkers according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines: for men, \> 14 drinks per week or ≥ 5 drinks per occasion at least once per month over the past 12 months; for women, \> 7 drinks per week or ≥ 4 drinks per occasion at least once per month over the past 12 months. A total of 274 participants will be randomized, 137 to each medication group.

Eligibility criteria: Inclusion Criteria:

1. Be treatment-seeking for smoking cessation and have a desire to reduce or quit drinking
2. Be between the ages of 21 and 65
3. Be able to provide informed consent
4. Smoke 5 or more cigarettes per day for the past year
5. Currently drink heavily according to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) guidelines: for men, \> 14 drinks per week or ≥ 5 drinks per occasion at least once per month over the past 12 months; for women, \> 7 drinks per week or ≥ 4 drinks per occasion at least once per month over the past 12 months
6. Pass the physical exam and associated laboratory tests, as determined by study physician

Exclusion Criteria:

1. Have clinically significant alcohol withdrawal, indicated by a score ≥ 10 on the Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) and assessed at the in-person screening visits
2. Have lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, a psychotic disorder, or any other psychiatric disorder as determined by the clinical interview
3. Have major depressive disorder within the past year requiring treatment as determined by the clinical interview using DSM-V criteria
4. Have a current or lifetime DSM-V diagnosis of a substance use disorder, other than for alcohol or nicotine, as determined by the clinical interview
5. Have a prior history of taking FDA approved medications (i.e. varenicline or bupropion) for smoking cessation
6. Be currently using any forms of nicotine replacement therapy (past use is acceptable)
7. Be currently using tobacco products other than cigarettes (such as e-cigarettes, cigars, or chewing tobacco)
8. Have a serious medical illness (significant cardiovascular disease; uncontrolled hypertension; hepatic or renal disease) that would contraindicate participation, as determined by the study physician
9. Be currently taking insulin or oral hypoglycemic medication
10. Be currently taking opioid pain medications or any form of opioid agonist maintenance therapy (such as methadone or buprenorphine)
11. Be currently taking any other psychoactive medications; such as anti-depressants, mood stabilizers, anti-seizure medications, sedatives-hypnotics, anxiolytics, stimulants or antipsychotics
12. Have self-reported use of cocaine, methamphetamine, heroin or other illicit drugs in the previous 60 days, verified by urine toxicology screen
13. For women, must not be pregnant (as indicated by self-report or a positive pregnancy test at any study visit), nursing, or planning to become pregnant while taking part in the study, and must agree to a reliable method of birth control

Primary outcomes:
measure: Number of Participants With Expired Carbon Monoxide Level <=5ppm
timeFrame: 26 weeks post-quit
Secondary outcomes:
measure: Drinks Per Drinking Day
timeFrame: 26 weeks post-quit
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Addictions Laboratory
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Lara Ray, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.