Recruiting
Phase 2
Phase 3

Bupropion vs. Naltrexone

Sponsor:

University of Minnesota

Code:

NCT00419731

Conditions

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Bupropion

Bupropion + Naltrexone

Study Details

Brief summary:

The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.

Conditions

Tobacco Use Disorder

Study ID

NCT00419731

Start date

Nov, 2006

Status verified date

Dec, 2009

Completion date

Jul, 2010

Anticipated

Primary completion date

Feb, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18 years and older.
  • Smoked at least 10 cigarettes/day for at least 1 year.
  • English speaking.
  • Females who are of childbearing potential must practice effective contraception and meet the following criteria:
  • Are instructed to avoid pregnancy through 30 days after the last dose of study medication.
  • Have a negative urine pregnancy test at baseline.
  • Agree to use of the birth control methods listed: an oral contraceptive agent, an intrauterine device (IUD), an implantable contraceptive (e.g., Norplant), or an injectable contraceptive (e.g., Depo-Provera) for at least one month prior to entering the study and will continue its use through at least 30 days after the last dose of the study medication. A barrier method of contraception (e.g., condom or diaphragm with spermicide) while participating in the study and 30 days after the last dose of study medication.
  • Willingness to reduce alcohol consumption during study to 2 or fewer standard drinks/day (3 oz. of alcohol or two beers (12 oz.), or two 5 oz. glasses of wine).
  • Willingness to not use illicit drugs during study period including marijuana.

Exclusion Criteria:

  • Concurrent use of tobacco products (other than cigarettes) or nicotine products.
  • Contraindications to use of bupropion (i.e., concurrent use of other forms of bupropion, MAO inhibitors, anti-depressant medication, seizure disorder or any clinical situation that might increase risk for seizures, past head injury, current or prior diagnosis of bulimia or anorexia nervosa; bipolar disorder).
  • Contraindications to use of naltrexone (i.e., past history of opioid abuse or dependence or evidence of opioid use in the past 30 days; significant hepatocellular injury as evidenced by liver enzyme levels over 3 times normal limits).
  • Use of medications whose metabolism or effects may be adversely altered by bupropion or naltrexone. Medications that contraindicate the use of bupropion include theophylline, procarbazine, carbimazole, nialamide, pargyline, toloxatone, iproniazid, and systemic steroids. Medications that contraindicate the use of naltrexone include opioid analgesics and yohimbine.
  • Current use of anti-seizure medications, disulfiram, or any medications that significantly challenge liver functioning.
  • Treatment for drug or alcohol dependence during the last year, or evidence of alcohol abuse so severe that the patient is judged potentially unable to comply with the protocol.
  • Evidence of problem alcohol consumption based on AUDIT.
  • Self-reported use of illicit drugs in the past 90 days (including opioids, but excluding marijuana).
  • Suicidal or homicidal ideation.
  • Current major depression.
  • History of bipolar disorder.
  • Recent (within twelve months) myocardial infarction.
  • Pregnant or lactating or planning pregnancy during treatment period.
  • Having plans to leave the immediate geographical area within 9 months.
  • Unwillingness or inability to given written informed consent.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 1

Bupropion+Placebo

experimental: 2

Bupropion+Naltrexone

Interventions

Bupropion

Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.

Placebo, 25 mg, q.d., for 7 weeks.

Bupropion + Naltrexone

Bupropion, Sustained-release, 150 mg, q.d., for days 1-3, 150 mg, b.i.d., for balance of 7 weeks.

Naltrexone, 25 mg, q.d., for 7 weeks.

Primary outcome measure

  • Biochemically-verified point-prevalence abstinence [ Time Frame: 7, 11, 16, and 30 weeks post-quit ]
  • Likelihood of progression to a relapse (e.g., return to baseline smoking) following a slip at any time in study. [ Time Frame: At any point following the quit date. ]
  • Treatment completion. [ Time Frame: Weeks 7 and 30. ]
  • Daily cigarette smoking rate. [ Time Frame: Weekly ]
  • Frequency and severity of bupropion and naltrexone side effects. [ Time Frame: Weekly during treatment ]

Central Contacts and Locations

Central contacts

Marc E Mooney, Ph.D.

612-273-9732moon0078@umn.edu

Dorothy K Hatsukami, Ph.D.

612-626-2121hatsu001@umn.edu

Locations

Tobacco Use Research Center, University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Marc E Mooney, Ph.D.

612-273-9732moon0078@umn.edu

Principal Investigator:

Marc E Mooney, Ph.D.

More Information

Sponsor

University of Minnesota

Last update posted

Dec 3, 2009

Last verified

Dec, 2009

Keywords

  • nicotine
  • smoking
  • addiction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2009-12-03.