Combining Varenicline and Naltrexone for Smoking Cessation

University of California, Los Angeles (UCLA)

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence; Alcohol Use Disorder

Treatments: Drug: Varenicline plus Naltrexone; Drug: Varenicline

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02698215

R01DA041226 (U.S. NIH Grant/Contract)

VAR-NTX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 165 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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165 participants in 2 patient groups, including a placebo group

Varenicline plus Naltrexone

Experimental group

Description:

VAR (1 mg twice daily) + NTX (50 mg once daily)

Treatment:

Drug: Varenicline plus Naltrexone

Varenicline

Placebo Comparator group

Description:

VAR (1 mg twice daily)

Treatment:

Drug: Varenicline