Nicotine DependencePhase 2NCT02698215

Combining Varenicline and Naltrexone for Smoking Cessation

A Phase 2 study testing Varenicline and Varenicline plus Naltrexone in people with Nicotine Dependence and Alcohol Use Disorder, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Nicotine Dependence, Alcohol Use Disorder
What is being tested?: Varenicline and Varenicline plus Naltrexone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: 1 siteUnited States
Study dates: May 2016to Dec 2019
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Show all 13Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Addictions Laboratory
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction

Read the 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.

Conditions: Nicotine Dependence, Alcohol Use Disorder
Being tested: Varenicline, Varenicline plus Naltrexone
Medical subject headings: Tobacco Use Disorder, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VareniclineDrug
Also called Chantix
Varenicline 1 mg twice daily
Varenicline plus NaltrexoneDrug
Also called Chantix, Revia
Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily

Study groups in NCT02698215
Study group	Role	What they receive
Varenicline plus Naltrexone	Experimental	VAR (1 mg twice daily) + NTX (50 mg once daily) Receives: Drug: Varenicline plus Naltrexone
Varenicline	Placebo comparator	VAR (1 mg twice daily) Receives: Drug: Varenicline

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 26 weeks post-quit

Secondary outcomes (1)

Drinks Per Drinking Day
Outcome for drinking reduction aim - Number of Drinks per Drinking Day
Measured: 26 weeks post-quit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Dec 2019

First posted3 Mar 2016 (estimated)
Study startMay 2016
Primary completionDec 2019
Study completionDec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Nicotine DependenceStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02698215
Sponsor's protocol ID: VAR-NTX
Other IDs: R01DA041226
Status last verified: May 2021
First submitted: 19 Feb 2016
Last updated: 15 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

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.
PubMed 34968106
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.
PubMed 34080890

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Young Adult Tobacco/Nicotine and Cannabis Co-use
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Social Media Support Groups for Adolescent Vaping Cessation
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The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
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Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
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§SMOKE Nicotine and Tobacco Youth Cohort
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All Nicotine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction
ClinicalTrials.gov ID: NCT02698215
Acronym / sponsor ID: VAR-NTX
Conditions: Nicotine Dependence, Alcohol Use Disorder
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: May 2016 (actual)
Primary completion: Dec 2019 (actual)
Study completion: Dec 2019 (actual)
First posted: 3 Mar 2016 (estimated)
Results: Posted 15 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Varenicline plus Naltrexone	Experimental	Drug: Varenicline plus NaltrexoneVAR (1 mg twice daily) + NTX (50 mg once daily)
Varenicline	Placebo comparator	Drug: VareniclineVAR (1 mg twice daily)

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (13 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VareniclineAlso: ChantixVarenicline 1 mg twice daily	Drug	Varenicline
Varenicline plus NaltrexoneAlso: Chantix, ReviaVarenicline 1 mg twice daily plus Naltrexone 50 mg once daily	Drug	Varenicline plus Naltrexone

Primary outcome

Number of Participants With Expired Carbon Monoxide Level <=5ppm
Time frame: 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.

1 secondary outcome

Drinks Per Drinking Day
Time frame: 26 weeks post-quit

Results and safety

Results posted to the registry on 15 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Varenicline Plus Naltrexone	83	55
Varenicline	82	64

Primary outcome: Number of Participants With Expired Carbon Monoxide Level <=5ppm

Time frame: 26 weeks post-quit. Count of participants. Unit: Participants

Measure	Varenicline Plus Naltrexone n = 83	Varenicline n = 82
Value	22	37

Population analysed: Intent to Treat.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected at each in-person visit (6 visits) during the medication period (approximately 12 weeks or 3 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Varenicline Plus Naltrexone	0 of 83 (0%)	63 of 83 (75.9%)	0 of 83
Varenicline	0 of 82 (0%)	64 of 82 (78%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34968106Green 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.
Derived from this study: PubMed 34080890Ray 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.
Individual participant dataSharing planned: No

Related trials for Nicotine Dependence

Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
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Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
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RecruitingObservational study
§SMOKE Nicotine and Tobacco Youth Cohort
Tobacco Use Behavior, Nicotine Dependence Tobacco Product

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lara Ray, PhD principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Expired Carbon Monoxide Level <=5ppm (time frame: 26 weeks post-quit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02698215, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2021.