Pharmacologic Relapse Prevention for Alcoholic Smokers
2 other identifiers
interventional
195
1 country
1
Brief Summary
This study will compare the long-term use of bupropion (Wellbutrin) and placebo for reducing the rate of smoking relapse in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy. The study will also determine the cessation rate in the 8th week of treatment among recovering alcoholics using a nicotine patch. The patch dose is projected to serve as a 100-percent replacement.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 1998
Longer than P75 for phase_2
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
June 1, 1998
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
November 3, 1999
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedOctober 21, 2013
October 1, 2013
3.8 years
November 2, 1999
October 18, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Will bupropion reduce relapse to smoking compared to placebo
Determine if long-term use of bupropion will reduce the rate of relapse to smoking compared to placebo in recovering alcoholics who achieved initial abstinence from smoking with nicotine patch therapy projected to achieve 100% replacement.
52 weeks and 76 weeks
Secondary Outcomes (1)
Does matching the dose of nicotine patches to nicotine levels help increase smoking abstinence
8 weeks
Study Arms (2)
Placebo
PLACEBO COMPARATORSubjects who achieved smoking abstinence and give a bupropion-placebo (sugar) pill for 44 weeks in order to prevent relapse to smoking. Brief Behavioral Counseling is also given during this time.
Bupropion
ACTIVE COMPARATORSubjects who achieved smoking abstinence and give bupropion (300 mg/day) for 44 weeks in order to prevent relapse to smoking. Brief Behavioral Counseling is also given during this time.
Interventions
1 pill in the am of 150 mg of Bupropion 1 pill (150 mg) in the AM and one in the PM for a total of 300 mg per day for subsequent 44 weeks.
placebo pill to match (look alike) the 150 mg pill of the bupropion given in the am for 3 days and then two pills (one in the morning and one at night) for the subsequent 44 mg.
Eligibility Criteria
You may qualify if:
- History of alcohol dependence and at least one year of abstinence from alcohol intake.
- Has a history of smoking 20 or more cigarettes per day for the prior year.
- Can read and write English.
- Stated ability to fully participate in the study and keep all scheduled appointments.
- Has provided written informed consent.
- General good health.
You may not qualify if:
- Recent history (within three months) of a clinically significant myocardial infarction, unstable angina pectoris, serious cardiac arrhythmia or any other medical condition which the physician investigator deems incompatible with study participation.
- Current or previous use of bupropion (Wellbutrin).
- Active non- nicotine drug dependence.
- Past or current history of bipolar disorder, pain disorder or psychosis, schizophrenia, or other major psychiatric disorders.
- Current medically indicated use of psychiatric drugs.
- Females who are pregnant, lactating, or likely to become pregnant during the first year which includes the nicotine patch and bupropion (Wellbutrin) phase.
- History of severe skin allergies or evidence of severe chronic skin disorders.
- Current use of nicotine containing medication or tobacco products other than cigarettes.
- Current use (within 30 days of initiation of patch therapy) of the following medications for smoking cessation: clonidine, buspirone, or doxepin.
- A predisposition to seizures.
- A history of or current diagnosis of anorexia nervosa or bulimia.
- Medical disorder that would interfere with the absorption, metabolism, or excretion of bupropion (Wellbutrin).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Mayo Clinic Rochester
Rochester, Minnesota, 55905, United States
Related Publications (3)
Hurt RD, Patten CA, Offord KP, Croghan IT, Decker PA, Morris RA, Hays JT. Treating nondepressed smokers with alcohol dependence in sustained full remission: nicotine patch therapy tailored to baseline serum cotinine. J Stud Alcohol. 2005 Jul;66(4):506-16. doi: 10.15288/jsa.2005.66.506.
PMID: 16240558RESULTHays JT, Hurt RD, Decker PA, Croghan IT, Offord KP, Patten CA. A randomized, controlled trial of bupropion sustained-release for preventing tobacco relapse in recovering alcoholics. Nicotine Tob Res. 2009 Jul;11(7):859-67. doi: 10.1093/ntr/ntp077. Epub 2009 May 29.
PMID: 19483180RESULTHajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.
PMID: 37230961DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard D Hurt, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 2, 1999
First Posted
November 3, 1999
Study Start
June 1, 1998
Primary Completion
April 1, 2002
Study Completion
August 1, 2007
Last Updated
October 21, 2013
Record last verified: 2013-10