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

Primary Purpose

Smoking, Nicotine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Bupropion
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking focused on measuring Tobacco, Smoking, Weight, Weight perception, Naltrexone, Bupropion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Yale University School of Medicine Substance Abuse Treatment Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupropion only

Naltrexone +Bupropion

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Smoking Cessation
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Point Prevalence Abstinence
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Weight Gain
Weight gain for for the entire sample in pounds at 6 weeks.

Secondary Outcome Measures

Weight Gain Abstinent Participants
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.

Full Information

First Posted
August 9, 2005
Last Updated
November 18, 2020
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00129246
Brief Title
Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Official Title
Naltrexone & Bupropion to Stop Smoking With Less Weight Gain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Nicotine Dependence
Keywords
Tobacco, Smoking, Weight, Weight perception, Naltrexone, Bupropion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupropion only
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Naltrexone +Bupropion
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Intervention Description
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
Intervention Name(s)
Bupropion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Smoking Cessation
Description
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Time Frame
Week 6
Title
Point Prevalence Abstinence
Description
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Time Frame
Week 6
Title
Weight Gain
Description
Weight gain for for the entire sample in pounds at 6 weeks.
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Weight Gain Abstinent Participants
Description
Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin Toll, Ph.D.
Organizational Affiliation
Yale University School of Medicine Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine Substance Abuse Treatment Unit
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17587504
Citation
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.
Results Reference
result

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

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