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

This study has been completed.

First Received: August 9, 2005 Last Updated: November 26, 2007 History of Changes

Sponsor:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by:	National Institute on Alcohol Abuse and Alcoholism (NIAAA)
ClinicalTrials.gov Identifier:	NCT00129246

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 I Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Control: Historical Control Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group 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 National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Primary Outcome Measures:

Weight gain and smoking cessation
Compliance with medication

Secondary Outcome Measures:

Alcohol consumption
Tobacco and food craving
Adverse events

Estimated Enrollment:	20
Study Start Date:	December 2004
Study Completion Date:	December 2005

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

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

Additional Information:

This website describes the Transdisciplinary Tobacco Use Research Center at Yale University. Click here for more information about the study: Naltrexone & Bupropion to Stop Smoking With Less Weight Gain. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	NIAAAOMA15632-B, NIH Grant 9 P50-AA15632
Study First Received:	August 9, 2005
Last Updated:	November 26, 2007
ClinicalTrials.gov Identifier:	NCT00129246 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Alcohol Abuse and Alcoholism (NIAAA):

Tobacco
Smoking
Weight

Weight perception
Naltrexone
Bupropion

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Psychotropic Drugs
Disorders of Environmental Origin
Body Weight
Signs and Symptoms
Habits
Smoking
Mental Disorders
Sensory System Agents

Therapeutic Uses
Body Weight Changes
Substance-Related Disorders
Antidepressive Agents, Second-Generation
Antidepressive Agents
Tobacco Use Disorder
Weight Gain
Pharmacologic Actions
Bupropion
Naltrexone
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on March 18, 2010