Study of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00419731
First received: January 8, 2007
Last updated: December 2, 2009
Last verified: December 2009
  Purpose

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


Condition Intervention Phase
Tobacco Use Disorder
Drug: Bupropion
Drug: Bupropion + Naltrexone
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Biochemically-verified point-prevalence abstinence [ Time Frame: 7, 11, 16, and 30 weeks post-quit ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Treatment completion. [ Time Frame: Weeks 7 and 30. ] [ Designated as safety issue: No ]
  • Daily cigarette smoking rate. [ Time Frame: Weekly ] [ Designated as safety issue: No ]
  • Frequency and severity of bupropion and naltrexone side effects. [ Time Frame: Weekly during treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Attentional bias. [ Time Frame: Weeks 1, 3, and 7. ] [ Designated as safety issue: No ]
  • Impulsivity. [ Time Frame: Weeks 1, 3, and 7. ] [ Designated as safety issue: No ]
  • Nicotine withdrawal, craving and negative/positive affect. [ Time Frame: All visits. ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: November 2006
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bupropion+Placebo
Drug: 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.

Experimental: 2
Bupropion+Naltrexone
Drug: 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.


Detailed Description:

The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit. Bupropion is an FDA-approved medication for smoking cessation that is believed to provide relief from craving and withdrawal through promotion of two neurotransmitter chemicals, dopamine and noradrenaline. Naltrexone is an FDA-approved medication for the treatment of opiate and alcohol dependence, that appears to function through blocking certain opiate receptors in the brain. It is expected that bupropion + naltrexone will produce higher smoking quit rates than bupropion + placebo. Bupropion alone is effective in alleviating some nicotine withdrawal complaints and craving for nicotine. However, bupropion does not reduce the rewarding effects of slips to smoking. Naltrexone alone is not generally effective as a smoking cessation medication, but it does help to reduce the rewarding effects of slips to smoking. Thus, it may help to prevent full relapse to smoking. In addition, naltrexone can help to reduce craving for cigarettes. It is hypothesized that the differing complementary actions of the two drugs will help smokers more than bupropion alone. In addition to examining smoking quit rates, the proposed study will also look at psychological processes that change during smoking cessation including, nicotine withdrawal, nicotine craving, mood, impulsivity, and attention

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419731

Contacts
Contact: Marc E Mooney, Ph.D. 612-273-9732 moon0078@umn.edu
Contact: Dorothy K Hatsukami, Ph.D. 612-626-2121 hatsu001@umn.edu

Locations
United States, Minnesota
Tobacco Use Research Center, University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55414
Contact: Marc E Mooney, Ph.D.    612-273-9732    moon0078@umn.edu   
Principal Investigator: Marc E Mooney, Ph.D.         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Marc E Mooney, Ph.D. Univerisity of Minnesota
  More Information

Additional Information:
Publications:

Responsible Party: Marc E. Mooney, Ph.D., University of Minnesota
ClinicalTrials.gov Identifier: NCT00419731     History of Changes
Other Study ID Numbers: K01-DA019446-01, K01DA019446-01, DPMC
Study First Received: January 8, 2007
Last Updated: December 2, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by National Institute on Drug Abuse (NIDA):
nicotine
smoking
addiction

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Naltrexone
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014