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Combining Varenicline and Naltrexone for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02698215
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Lara Ray, 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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Alcohol Use Disorder Drug: Varenicline Drug: Varenicline plus Naltrexone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction
Study Start Date : March 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Varenicline plus Naltrexone
VAR (1 mg twice daily) + NTX (50 mg once daily)
Drug: Varenicline plus Naltrexone
Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily
Other Names:
  • Chantix
  • Revia

Placebo Comparator: Varenicline
VAR (1 mg twice daily)
Drug: Varenicline
Varenicline 1 mg twice daily
Other Name: Chantix




Primary Outcome Measures :
  1. Expired carbon monoxide level [ Time Frame: 26 weeks post-quit ]
    smoking cessation outcome


Secondary Outcome Measures :
  1. Drinks per drinking day [ Time Frame: 26 weeks post-quit ]
    drinking outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698215


Contacts
Contact: Jessica Jenkins, MA 310-206-6756 raylab@psych.ucla.edu
Contact: Taylor Rohrbaugh, BA 310-206-6756 raylab@psych.ucla.edu

Locations
United States, California
UCLA Addictions Laboratory Recruiting
Los Angeles, California, United States, 90095
Contact: Jessica Jenkins, MA    310-206-6756    raylab@psych.ucla.edu   
Principal Investigator: Lara Ray, PhD         
Sub-Investigator: Adam Levanthal, PhD         
Sub-Investigator: Karen Miotto, MD         
Sub-Investigator: Keith Heinzerling, MD         
Sub-Investigator: Gang Li, PhD         
Sponsors and Collaborators
University of California, Los Angeles
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Lara Ray, PhD University of California, Los Angeles

Responsible Party: Lara Ray, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02698215     History of Changes
Other Study ID Numbers: VAR-NTX
R01DA041226 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Varenicline
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action