- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00129246
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
November 18, 2020 updated by: Yale University
Naltrexone & Bupropion to Stop Smoking With Less Weight Gain
This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine:
- effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and
- compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Connecticut
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New Haven, Connecticut, United States, 06511
- Yale University School of Medicine Substance Abuse Treatment Unit
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ages 18 and older
- Willingness and ability to give written consent
- Smoking at least 10 cigarettes per day for at least 1 year
- Baseline expired carbon-monoxide level of at least 10 ppm
- Weigh at least 100 lbs.
- English-speaking
- One person per household
- At least 1 prior quit attempt
- Concern about gaining weight. This will be assessed using a questionnaire that will provide a rating system to determine qualified participants.
Exclusion Criteria:
- Pregnant or nursing women or women attempting to conceive
- Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension
- Current alcohol dependence
- Current use of opiates, and/or a urine toxicology screen positive for opiates
- Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)
- Evidence of significant hepatocellular injury as evidenced by AST or ALT >3 x normal or elevated bilirubin
- History of cirrhosis
- Body mass index (BMI) greater than 35
- History of anorexia nervosa or bulimia
- Current major depression
- Currently taking Toprol-XL (or metoprolol succinate)
- History of seizure disorder or serious brain injury
- Current use of smokeless tobacco, pipes, cigars, nicotine gum, nicotine patch, nicotine inhaler, nicotine lozenge, nicotine nasal spray, or bupropion
- Previous hypersensitivity to bupropion
- Patients requiring concomitant therapy with any psychotropic drug
- Participation in the Framing Messages for Smoking Cessation With Bupropion study (HIC#: 10880)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bupropion only
The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).
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Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
|
Experimental: Naltrexone +Bupropion
The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).
|
Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.
Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoking Cessation
Time Frame: Week 6
|
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
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Week 6
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Point Prevalence Abstinence
Time Frame: Week 6
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Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
|
Week 6
|
Weight Gain
Time Frame: Week 6
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Weight gain for for the entire sample in pounds at 6 weeks.
|
Week 6
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight Gain Abstinent Participants
Time Frame: Week 6
|
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
|
Week 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Benjamin Toll, Ph.D., Yale University School of Medicine Department of Psychiatry
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2004
Study Completion (Actual)
December 1, 2005
Study Registration Dates
First Submitted
August 9, 2005
First Submitted That Met QC Criteria
August 9, 2005
First Posted (Estimate)
August 11, 2005
Study Record Updates
Last Update Posted (Actual)
December 3, 2020
Last Update Submitted That Met QC Criteria
November 18, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Body Weight
- Body Weight Changes
- Tobacco Use Disorder
- Weight Gain
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Narcotic Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Alcohol Deterrents
- Dopamine Uptake Inhibitors
- Naltrexone
- Bupropion
Other Study ID Numbers
- NIAAAOMA15632-B
- P50AA015632 (U.S. NIH Grant/Contract)
- NIH Grant 9 P50-AA15632
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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