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

NCT ID: NCT00129246

Last Updated: 2020-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-12-31
• Study Completion Date: 2005-12-31

Brief Summary

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.

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.

Conditions

Smoking; Nicotine Dependence

Keywords

Tobacco; Smoking; Weight; Weight perception; Naltrexone; Bupropion

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Bupropion

Intervention Type: DRUG

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.

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).

Group Type: EXPERIMENTAL

Naltrexone

Intervention Type: DRUG

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.

Bupropion

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Toll, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Medicine, Department of Psychiatry

Locations

Yale University School of Medicine Substance Abuse Treatment Unit

New Haven, Connecticut, United States

Countries

United States

References

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. doi: 10.1016/j.addbeh.2007.05.012. Epub 2007 Jun 2.

Reference Type: RESULT

PMID: 17587504 (View on PubMed)

Other Identifiers

P50AA015632

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant 9 P50-AA15632

Identifier Type: -

Identifier Source: secondary_id

NIAAAOMA15632-B

Identifier Type: -

Identifier Source: org_study_id