Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain - Full Text View

Purpose

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.

Condition	Intervention	Phase
Smoking Nicotine Dependence	Drug: Naltrexone Drug: Bupropion	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Naltrexone & Bupropion to Stop Smoking With Less Weight Gain

Resource links provided by NLM:

MedlinePlus related topics: Quitting Smoking Smoking

Drug Information available for: Naltrexone Naltrexone hydrochloride Bupropion hydrochloride Bupropion

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Smoking Cessation [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Point Prevalence Abstinence [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Weight Gain [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Weight gain for for the entire sample in pounds at 6 weeks.

Secondary Outcome Measures:

Weight Gain Abstinent Participants [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.

Enrollment:	40
Study Start Date:	December 2004
Study Completion Date:	December 2005

Arms	Assigned Interventions
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).	Drug: Bupropion 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).	Drug: Naltrexone 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. Drug: Bupropion 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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00129246

Locations

United States, Connecticut
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Yale University

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Investigators

Principal Investigator:

Benjamin Toll, Ph.D.

Yale University School of Medicine Department of Psychiatry

More Information

Publications:

Toll BA, Leary V, Wu R, Salovey P, Meandzija B, O'Malley SS. A preliminary investigation of naltrexone augmentation of bupropion to stop smoking with less weight gain. Addict Behav. 2008 Jan;33(1):173-9. Epub 2007 Jun 2.

Responsible Party:	Benjamin A. Toll, Associate Professor, Yale University
ClinicalTrials.gov Identifier:	NCT00129246 History of Changes
Other Study ID Numbers:	NIAAAOMA15632-B, P50AA015632, NIH Grant 9 P50-AA15632
Study First Received:	August 9, 2005
Results First Received:	January 2, 2013
Last Updated:	January 2, 2013
Health Authority:	United States: Federal Government

Keywords provided by Yale University:

Tobacco
Smoking
Weight

Weight perception
Naltrexone
Bupropion

Additional relevant MeSH terms:

Tobacco Use Disorder
Smoking
Weight Gain
Substance-Related Disorders
Mental Disorders
Habits
Body Weight Changes
Body Weight
Signs and Symptoms
Naltrexone
Bupropion
Narcotic Antagonists
Physiological Effects of Drugs

Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013