Trial · NCT00502216

Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

NCT00502216, Phase 1, Phase 2, Completed, Yale University; results first posted 2010-09-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers. Trials, record NCT00502216. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00502216

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers
NCT number: NCT00502216
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 40 participants, actual
Lead sponsor: Yale University
Conditions: Smoking, Nicotine Dependence
Interventions: Naltrexone, Varenicline
First posted: 2007-07-17
Last updated: 2018-01-17
Results first posted: 2010-09-21

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Weight Gain in Treatment Completers	baseline and 12 weeks
Secondary	Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment	4 weeks
Secondary	Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline	11 weeks	Tolerability was measured by tracking adverse events. These data are reported in detail in the adverse events section. Presented are an unduplicated count of participants that experienced at least 1 adverse event.

Source ClinicalTrials.gov

Outcomes3

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Weight Gain in Treatment Completers	baseline and 12 weeks	Subpopulation of participants who reported quitting smoking	Pounds	MEAN
SECONDARY	Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment	4 weeks	Analyzed are those that remained abstinent for last 4 weeks of treatment	pounds	MEAN
SECONDARY	Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline	11 weeks		Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Weight Gain in Treatment Completers	Varenicline + Naltrexone	3.35	Standard Deviation 6.61	Pounds
Weight Gain in Treatment Completers	Varenicline + Placebo	4.14	Standard Deviation 5.15	Pounds
Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment	Varenicline + Naltrexone	0	Standard Deviation 4.36	pounds
Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment	Varenicline + Placebo	7.67	Standard Deviation 2.31	pounds
Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline	Varenicline + Naltrexone	10		Participants
Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline	Varenicline + Placebo	4		Participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Varenicline + Naltrexone	21
Overall Study	STARTED	Varenicline + Placebo	19
Overall Study	COMPLETED	Varenicline + Naltrexone	21
Overall Study	COMPLETED	Varenicline + Placebo	19
Overall Study	NOT COMPLETED	Varenicline + Naltrexone	0
Overall Study	NOT COMPLETED	Varenicline + Placebo	0

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nausea	General disorders	Varenicline + Naltrexone	6	21
other	Nausea	General disorders	Varenicline + Placebo	0	0
other	Anxiety	Psychiatric disorders	Varenicline + Naltrexone	3	21
other	Anxiety	Psychiatric disorders	Varenicline + Placebo	1	19
other	Constipation	Gastrointestinal disorders	Varenicline + Naltrexone	3	21
other	Constipation	Gastrointestinal disorders	Varenicline + Placebo	1	19
other	Fatigue	General disorders	Varenicline + Naltrexone	4	21
other	Fatigue	General disorders	Varenicline + Placebo	0	19
other	Depression	Psychiatric disorders	Varenicline + Naltrexone	3	21
other	Depression	Psychiatric disorders	Varenicline + Placebo	0	19

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Varenicline + Naltrexone
Total, all-cause mortality	Varenicline + Placebo
Total, other adverse events	Varenicline + Naltrexone	10	21
Total, other adverse events	Varenicline + Placebo	4	19
Total, serious adverse events	Varenicline + Naltrexone	0	21
Total, serious adverse events	Varenicline + Placebo	0	19

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37142273	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P50AA015632	Tobacco Dependence & Risk Factors for Treatment Failure	O'MALLEY, STEPHANIE S	YALE UNIVERSITY	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2004 to 2008

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Varenicline + Naltrexone vs Varenicline + Placebo: Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline	Trial comparisons
Varenicline + Naltrexone vs Varenicline + Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00502216

GET https://conductscience.org/api/trials/v1/NCT00502216/events?page=2

API reference For AI assistants