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Sponsored by: |
National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
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Information provided by: | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
ClinicalTrials.gov Identifier: | NCT00105482 |
Weight gain after quitting smoking is an important barrier to treatment for many smokers. This study will test a drug called naltrexone with weight-concerned smokers to investigate whether or not this drug both improves smoking cessation quit rates and minimizes post quit weight gain.
Condition | Intervention | Phase |
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Nicotine Dependence |
Drug: Naltrexone Drug: Transdermal nicotine replacement Behavioral: Behavioral counseling |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Testing the Effectiveness of Low Dose Naltrexone for Smoking Cessation and Minimization of Post-Cessation Weight Gain |
Enrollment: | 172 |
Study Start Date: | January 2005 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day
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Drug: Naltrexone
Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks
Drug: Transdermal nicotine replacement
Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day
Behavioral: Behavioral counseling
Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
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2: Placebo Comparator
Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day
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Behavioral: Behavioral counseling
Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter.
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This is a 6-month randomized, double-blind, placebo controlled trial of 25 mg naltrexone for smoking cessation in a sample of 270 male and female weight-concerned smokers. Participants also receive transdermal nicotine replacement therapy during the first 8 weeks of the study, which they begin on their quit date. Naltrexone study medication will be started a week before their quit date and continued through the six-month period. Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter. A follow-up appointment is completed at 12 months after participants' quit date.
The primary outcomes are six-month point prevalence abstinence and post-cessation weight gain for those who are continuously abstinent (not even a puff).
Secondary outcomes include an examination of alcohol consumption, evaluation of urges, other measures of smoking cessation success, point prevalence abstinence at 12 months, and food preferences. A number of tertiary measures will be obtained for examining predictors of smoking cessation, weight gain, and naltrexone response.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |
Yale University School of Medicine Substance Abuse Treatment Unit | |
New Haven, Connecticut, United States, 06511 |
Principal Investigator: | Stephanie O'Malley, PhD | Yale School of Medicine |
Responsible Party: | Yale University ( Stephanie O'Malley, Ph.D., Professor ) |
Study ID Numbers: | NIAAAOMA15632, 9 P50-AA15632 |
Study First Received: | March 14, 2005 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00105482 History of Changes |
Health Authority: | United States: Federal Government |
Tobacco Smoking Weight Weight perception Naltrexone |
Nicotine polacrilex Neurotransmitter Agents Nicotinic Agonists Tobacco Use Disorder Narcotic Antagonists Disorders of Environmental Origin Narcotics Cholinergic Agents |
Weight Gain Body Weight Smoking Mental Disorders Nicotine Naltrexone Substance-Related Disorders Peripheral Nervous System Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Nicotinic Agonists Tobacco Use Disorder Narcotic Antagonists Physiological Effects of Drugs Disorders of Environmental Origin Cholinergic Agents Pharmacologic Actions |
Autonomic Agents Mental Disorders Nicotine Sensory System Agents Therapeutic Uses Naltrexone Ganglionic Stimulants Substance-Related Disorders Peripheral Nervous System Agents Central Nervous System Agents |