Combining Varenicline and Naltrexone for Smoking Cessation

Alcohol Use Disorder Clinical Trial

Official title:

Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02698215
• Other study ID #: VAR-NTX
• Secondary ID: R01DA041226
• Status: Completed
• Phase: Phase 2
• Start date: May 2016
• Est. completion date: December 2019

Study information

• Verified date: May 2021
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Nicotine Dependence
• Tobacco Use Disorder

Intervention

Drug:
• Varenicline
Varenicline 1 mg twice daily
• Varenicline plus Naltrexone
Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily

Locations

Country	Name	City	State
United States	UCLA Addictions Laboratory	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Expired Carbon Monoxide Level <=5ppm	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.	26 weeks post-quit
Secondary	Drinks Per Drinking Day	Outcome for drinking reduction aim - Number of Drinks per Drinking Day	26 weeks post-quit