Combining Varenicline and Naltrexone for Smoking Cessation

Phase 2

Completed

Conditions: Nicotine Dependence
Alcohol Use Disorder

Interventions: Drug: Varenicline plus Naltrexone
Drug: Varenicline

Registration Number: NCT02698215

Lead Sponsor: University of California, Los Angeles

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 165

Inclusion Criteria

Be treatment-seeking for smoking cessation and have a desire to reduce or quit drinking
Be between the ages of 21 and 65
Be able to provide informed consent
Smoke 5 or more cigarettes per day for the past year
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
Pass the physical exam and associated laboratory tests, as determined by study physician

Exclusion Criteria

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
Have lifetime DSM-V diagnosis of schizophrenia, bipolar disorder, a psychotic disorder, or any other psychiatric disorder as determined by the clinical interview
Have major depressive disorder within the past year requiring treatment as determined by the clinical interview using DSM-V criteria
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
Have a prior history of taking FDA approved medications (i.e. varenicline or bupropion) for smoking cessation
Be currently using any forms of nicotine replacement therapy (past use is acceptable)
Be currently using tobacco products other than cigarettes (such as e-cigarettes, cigars, or chewing tobacco)
Have a serious medical illness (significant cardiovascular disease; uncontrolled hypertension; hepatic or renal disease) that would contraindicate participation, as determined by the study physician
Be currently taking insulin or oral hypoglycemic medication
Be currently taking opioid pain medications or any form of opioid agonist maintenance therapy (such as methadone or buprenorphine)
Be currently taking any other psychoactive medications; such as anti-depressants, mood stabilizers, anti-seizure medications, sedatives-hypnotics, anxiolytics, stimulants or antipsychotics
Have self-reported use of cocaine, methamphetamine, heroin or other illicit drugs in the previous 60 days, verified by urine toxicology screen
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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Varenicline plus Naltrexone	Varenicline plus Naltrexone	VAR (1 mg twice daily) + NTX (50 mg once daily)
Varenicline	Varenicline	VAR (1 mg twice daily)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Expired Carbon Monoxide Level <=5ppm	26 weeks post-quit	Outcome for smoking cessation aim was Expired Carbon Monoxide level, which was used to determine whether a participant successfully abstained from cigarettes. 7 day point prevalence of nicotine abstinence was bioverified by Expired Carbon Monoxide reading of \<= 5ppm at the 26-week follow-up visit.

Secondary Outcome Measures