Clinical trial NCT00000457: Pharmacologic Relapse Prevention for Alcoholic Smokers
Official title: Pharmacologic Relapse Prevention for Alcoholic Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Smoking
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 1999-11-03
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Will bupropion reduce relapse to smoking compared to placebo
timeFrame: 52 weeks and 76 weeks
Secondary outcomes:
measure: Does matching the dose of nicotine patches to nicotine levels help increase smoking abstinence
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Richard D Hurt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.