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Pharmacologic Relapse Prevention for Alcoholic Smokers

Primary Purpose

Alcoholism, Smoking

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bupropion (Wellbutrin)
Placebo
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alcoholism

Eligibility Criteria

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

Inclusion Criteria: 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. Exclusion Criteria: 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 major depression. A past history of major depression will not be an exclusionary criteria. 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).

Sites / Locations

  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Bupropion

Arm Description

Subjects 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.

Subjects 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Does matching the dose of nicotine patches to nicotine levels help increase smoking abstinence
Determine the week 8 smoking cessation rate in recovering alcoholics provided a nicotine patch dose projected to achieve 100% replacement.

Full Information

First Posted
November 2, 1999
Last Updated
October 18, 2013
Sponsor
Mayo Clinic
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00000457
Brief Title
Pharmacologic Relapse Prevention for Alcoholic Smokers
Official Title
Pharmacologic Relapse Prevention for Alcoholic Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
June 1998 (undefined)
Primary Completion Date
April 2002 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Mayo Clinic
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The purpose of this trial was to recruit 292 recovering alcoholic smokers (abstinent from alcohol for a minimum of 1 year), who want to stop smoking and provide them with 100% nicotine replacement. The 100% nicotine replacement will be undertaken using a nicotine patch. By measuring their nicotine levels at study entry we can determine the patch dosing needed. The patch dosing will vary from 22 mg to 44 mg. Those who are able to achieve tobacco abstinence by week 8 will enter a relapse prevention phase for the remaining 44 weeks. In this phase, they will be randomized to active or placebo bupropion (300 mg/day). After 44 weeks of the relapse prevention trial (at week 52 of study participation), they will enter a post medication follow up for 6 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism, Smoking

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects 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.
Arm Title
Bupropion
Arm Type
Active Comparator
Arm Description
Subjects 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.
Intervention Type
Drug
Intervention Name(s)
bupropion (Wellbutrin)
Other Intervention Name(s)
bupropion, zyban, wellbutrin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
bupropion, zyban, wellbutrin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Will bupropion reduce relapse to smoking compared to placebo
Description
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.
Time Frame
52 weeks and 76 weeks
Secondary Outcome Measure Information:
Title
Does matching the dose of nicotine patches to nicotine levels help increase smoking abstinence
Description
Determine the week 8 smoking cessation rate in recovering alcoholics provided a nicotine patch dose projected to achieve 100% replacement.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 major depression. A past history of major depression will not be an exclusionary criteria. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard D Hurt, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16240558
Citation
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.
Results Reference
result
PubMed Identifier
19483180
Citation
Hays 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.
Results Reference
result

Learn more about this trial

Pharmacologic Relapse Prevention for Alcoholic Smokers

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