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Naltrexone and Varenicline: Weight Gain and Tolerability in Cigarette Smokers

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ClinicalTrials.gov Identifier: NCT00502216
Recruitment Status : Completed
First Posted : July 17, 2007
Results First Posted : September 21, 2010
Last Update Posted : January 17, 2018
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Smoking
Nicotine Dependence
Interventions Drug: Naltrexone
Drug: Varenicline
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Varenicline + Naltrexone Varenicline + Placebo
Hide Arm/Group Description Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Period Title: Overall Study
Started 21 19
Completed 21 19
Not Completed 0 0
Arm/Group Title Varenicline + Naltrexone Varenicline + Placebo Total
Hide Arm/Group Description Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day Total of all reporting groups
Overall Number of Baseline Participants 21 19 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants 19 participants 40 participants
50.29  (11.08) 42.42  (9.57) 46.55  (11.00)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants 19 participants 40 participants
Female
15
  71.4%
12
  63.2%
27
  67.5%
Male
6
  28.6%
7
  36.8%
13
  32.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 21 participants 19 participants 40 participants
21 19 40
1.Primary Outcome
Title Weight Gain in Treatment Completers
Hide Description [Not Specified]
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Subpopulation of participants who reported quitting smoking
Arm/Group Title Varenicline + Naltrexone Varenicline + Placebo
Hide Arm/Group Description:
Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Overall Number of Participants Analyzed 17 11
Mean (Standard Deviation)
Unit of Measure: Pounds
3.35  (6.61) 4.14  (5.15)
2.Secondary Outcome
Title Weight Gain in Participants Who Are Continuously Abstinent for the Last 4 Weeks of Treatment
Hide Description [Not Specified]
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Analyzed are those that remained abstinent for last 4 weeks of treatment
Arm/Group Title Varenicline + Naltrexone Varenicline + Placebo
Hide Arm/Group Description:
Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Overall Number of Participants Analyzed 3 3
Mean (Standard Deviation)
Unit of Measure: pounds
0  (4.36) 7.67  (2.31)
3.Secondary Outcome
Title Tolerability of the Combination of 25 mg Naltrexone and 2 mg Varenicline
Hide Description 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.
Time Frame 11 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Varenicline + Naltrexone Varenicline + Placebo
Hide Arm/Group Description:
Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
Overall Number of Participants Analyzed 21 19
Measure Type: Count of Participants
Unit of Measure: Participants
10
  47.6%
4
  21.1%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Varenicline + Naltrexone Varenicline + Placebo
Hide Arm/Group Description Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
All-Cause Mortality
Varenicline + Naltrexone Varenicline + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Varenicline + Naltrexone Varenicline + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Varenicline + Naltrexone Varenicline + Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   10/21 (47.62%)   4/19 (21.05%) 
Gastrointestinal disorders     
Constipation   3/21 (14.29%)  1/19 (5.26%) 
Flatulence   2/21 (9.52%)  1/19 (5.26%) 
Acid reflux   0/21 (0.00%)  1/19 (5.26%) 
Vomiting   1/21 (4.76%)  0/19 (0.00%) 
General disorders     
Nausea   6/21 (28.57%)  0/0 
Fatigue   4/21 (19.05%)  0/19 (0.00%) 
Joint pain   2/21 (9.52%)  1/19 (5.26%) 
Other   2/21 (9.52%)  1/19 (5.26%) 
Drowsiness   1/21 (4.76%)  0/19 (0.00%) 
Dry Mouth   1/21 (4.76%)  0/19 (0.00%) 
Headache   1/21 (4.76%)  0/19 (0.00%) 
Nightmares   1/21 (4.76%)  0/19 (0.00%) 
Sweating   1/21 (4.76%)  0/19 (0.00%) 
Metabolism and nutrition disorders     
Decreased Appetite   1/21 (4.76%)  0/19 (0.00%) 
Increased Appetite   1/21 (4.76%)  0/19 (0.00%) 
Nervous system disorders     
Dizzyness   1/21 (4.76%)  0/19 (0.00%) 
Psychiatric disorders     
Anxiety   3/21 (14.29%)  1/19 (5.26%) 
Depression   3/21 (14.29%)  0/19 (0.00%) 
Insomnia   3/21 (14.29%)  0/19 (0.00%) 
Sleepiness   2/21 (9.52%)  0/19 (0.00%) 
Vivid dreams   2/21 (9.52%)  0/19 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Benjamin Toll, Ph.D.
Organization: Yale University School of Medicine
Phone: 203-974-5767
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00502216     History of Changes
Other Study ID Numbers: 0704002538
P50AA015632 ( U.S. NIH Grant/Contract )
NIH Grant P50-AA15632
NIH Grant K12-DA00167
First Submitted: July 13, 2007
First Posted: July 17, 2007
Results First Submitted: June 3, 2010
Results First Posted: September 21, 2010
Last Update Posted: January 17, 2018