Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain
Naltrexone & Bupropion to Stop Smoking With Less Weight Gain
3 other identifiers
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 9, 2005
CompletedFirst Posted
Study publicly available on registry
August 11, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
February 5, 2013
CompletedDecember 3, 2020
November 1, 2020
August 9, 2005
January 2, 2013
November 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Smoking Cessation
Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.
Week 6
Point Prevalence Abstinence
Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.
Week 6
Weight Gain
Weight gain for for the entire sample in pounds at 6 weeks.
Week 6
Secondary Outcomes (1)
Weight Gain Abstinent Participants
Week 6
Study Arms (2)
Bupropion only
ACTIVE COMPARATORThe 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).
Naltrexone +Bupropion
EXPERIMENTALThe 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).
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale University School of Medicine Substance Abuse Treatment Unit
New Haven, Connecticut, 06511, United States
Related Publications (1)
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.
PMID: 17587504RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Benjamin A. Toll, PhD
- Organization
- Associate Professor of Psychiatry and Program Director, Smoking Cessation Service at Smilow Cancer Hospital at Yale-New Haven
Study Officials
- PRINCIPAL INVESTIGATOR
Benjamin Toll, Ph.D.
Yale University School of Medicine, Department of Psychiatry
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 9, 2005
First Posted
August 11, 2005
Study Start
December 1, 2004
Study Completion
December 1, 2005
Last Updated
December 3, 2020
Results First Posted
February 5, 2013
Record last verified: 2020-11