- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00419731
Study of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
December 2, 2009 updated by: University of Minnesota
Phase II Randomized, Double-Blind Trial of Bupropion Versus Bupropion + Naltrexone for Smoking Cessation
The purpose of this study is to compare the effects of bupropion + placebo to bupropion + naltrexone as treatments to help smokers quit.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Study Type
Interventional
Enrollment (Anticipated)
120
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marc E Mooney, Ph.D.
- Phone Number: 612-273-9732
- Email: moon0078@umn.edu
Study Contact Backup
- Name: Dorothy K Hatsukami, Ph.D.
- Phone Number: 612-626-2121
- Email: hatsu001@umn.edu
Study Locations
-
-
Minnesota
-
Minneapolis, Minnesota, United States, 55414
- Recruiting
- Tobacco Use Research Center, University of Minnesota
-
Contact:
- Marc E Mooney, Ph.D.
- Phone Number: 612-273-9732
- Email: moon0078@umn.edu
-
Principal Investigator:
- Marc E Mooney, Ph.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
Bupropion+Placebo
|
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
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biochemically-verified point-prevalence abstinence
Time Frame: 7, 11, 16, and 30 weeks post-quit
|
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.
|
At any point following the quit date.
|
Treatment completion.
Time Frame: Weeks 7 and 30.
|
Weeks 7 and 30.
|
Daily cigarette smoking rate.
Time Frame: Weekly
|
Weekly
|
Frequency and severity of bupropion and naltrexone side effects.
Time Frame: Weekly during treatment
|
Weekly during treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Attentional bias.
Time Frame: Weeks 1, 3, and 7.
|
Weeks 1, 3, and 7.
|
Impulsivity.
Time Frame: Weeks 1, 3, and 7.
|
Weeks 1, 3, and 7.
|
Nicotine withdrawal, craving and negative/positive affect.
Time Frame: All visits.
|
All visits.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Marc E Mooney, Ph.D., Univerisity of Minnesota
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Krishnan-Sarin S, Meandzija B, O'Malley S. Naltrexone and nicotine patch smoking cessation: a preliminary study. Nicotine Tob Res. 2003 Dec;5(6):851-7. doi: 10.1080/14622200310001614601.
- Williams J, Ziedonis DM. Naltrexone-bupropion combination therapy for protracted abstinence dysphoria. Am J Addict. 2003 May-Jun;12(3):270-2. No abstract available.
- Ascher JA, Cole JO, Colin JN, Feighner JP, Ferris RM, Fibiger HC, Golden RN, Martin P, Potter WZ, Richelson E, et al. Bupropion: a review of its mechanism of antidepressant activity. J Clin Psychiatry. 1995 Sep;56(9):395-401.
- Mooney ME, Sofuoglu M. Bupropion for the treatment of nicotine withdrawal and craving. Expert Rev Neurother. 2006 Jul;6(7):965-81. doi: 10.1586/14737175.6.7.965.
- Shiffman S, Johnston JA, Khayrallah M, Elash CA, Gwaltney CJ, Paty JA, Gnys M, Evoniuk G, DeVeaugh-Geiss J. The effect of bupropion on nicotine craving and withdrawal. Psychopharmacology (Berl). 2000 Jan;148(1):33-40. doi: 10.1007/s002130050022.
- King AC, Meyer PJ. Naltrexone alteration of acute smoking response in nicotine-dependent subjects. Pharmacol Biochem Behav. 2000 Jul;66(3):563-72. doi: 10.1016/s0091-3057(00)00258-6.
- Epstein AM, King AC. Naltrexone attenuates acute cigarette smoking behavior. Pharmacol Biochem Behav. 2004 Jan;77(1):29-37. doi: 10.1016/j.pbb.2003.09.017.
- King A, de Wit H, Riley RC, Cao D, Niaura R, Hatsukami D. Efficacy of naltrexone in smoking cessation: a preliminary study and an examination of sex differences. Nicotine Tob Res. 2006 Oct;8(5):671-82. doi: 10.1080/14622200600789767.
- Lerman C, Roth D, Kaufmann V, Audrain J, Hawk L, Liu A, Niaura R, Epstein L. Mediating mechanisms for the impact of bupropion in smoking cessation treatment. Drug Alcohol Depend. 2002 Jul 1;67(2):219-23. doi: 10.1016/s0376-8716(02)00067-4.
- Hutchison KE, Monti PM, Rohsenow DJ, Swift RM, Colby SM, Gnys M, Niaura RS, Sirota AD. Effects of naltrexone with nicotine replacement on smoking cue reactivity: preliminary results. Psychopharmacology (Berl). 1999 Feb;142(2):139-43. doi: 10.1007/s002130050872.
- Wong GY, Wolter TD, Croghan GA, Croghan IT, Offord KP, Hurt RD. A randomized trial of naltrexone for smoking cessation. Addiction. 1999 Aug;94(8):1227-37. doi: 10.1046/j.1360-0443.1999.948122713.x.
- Brauer LH, Behm FM, Westman EC, Patel P, Rose JE. Naltrexone blockade of nicotine effects in cigarette smokers. Psychopharmacology (Berl). 1999 Apr;143(4):339-46. doi: 10.1007/s002130050957.
- Ahmadi J, Ashkani H, Ahmadi M, Ahmadi N. Twenty-four week maintenance treatment of cigarette smoking with nicotine gum, clonidine and naltrexone. J Subst Abuse Treat. 2003 Apr;24(3):251-5. doi: 10.1016/s0740-5472(03)00027-8.
- Sutherland G, Stapleton JA, Russell MA, Feyerabend C. Naltrexone, smoking behaviour and cigarette withdrawal. Psychopharmacology (Berl). 1995 Aug;120(4):418-25. doi: 10.1007/BF02245813.
- Wewers ME, Dhatt R, Tejwani GA. Naltrexone administration affects ad libitum smoking behavior. Psychopharmacology (Berl). 1998 Nov;140(2):185-90. doi: 10.1007/s002130050756.
- Covey LS, Glassman AH, Stetner F. Naltrexone effects on short-term and long-term smoking cessation. J Addict Dis. 1999;18(1):31-40. doi: 10.1300/J069v18n01_04.
- Lerner AG, Oyffe I, Sigal M. Naltrexone-induced reduction of tobacco intake. J Clin Psychiatry. 1998 Jan;59(1):30-1. doi: 10.4088/jcp.v59n0107c. No abstract available.
- David S, Lancaster T, Stead LF. Opioid antagonists for smoking cessation. Cochrane Database Syst Rev. 2001;(3):CD003086. doi: 10.1002/14651858.CD003086.
- Toll BA, Leary V, Wu R, Salovey P, Meandzija B, O'Malley SS. A preliminary investigation of naltrexone augmentation of bupropion to stop smoking with less weight gain. Addict Behav. 2008 Jan;33(1):173-9. doi: 10.1016/j.addbeh.2007.05.012. Epub 2007 Jun 2.
- Plodkowski RA, Nguyen Q, Sundaram U, Nguyen L, Chau DL, St Jeor S. Bupropion and naltrexone: a review of their use individually and in combination for the treatment of obesity. Expert Opin Pharmacother. 2009 Apr;10(6):1069-81. doi: 10.1517/14656560902775750.
- Mooney ME, Schmitz JM, Allen S, Grabowski J, Pentel P, Oliver A, Hatsukami DK. Bupropion and naltrexone for smoking cessation: A double-blind randomized placebo-controlled clinical trial. Clin Pharmacol Ther. 2016 Oct;100(4):344-52. doi: 10.1002/cpt.402. Epub 2016 Jun 20.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Anticipated)
February 1, 2010
Study Completion (Anticipated)
July 1, 2010
Study Registration Dates
First Submitted
January 8, 2007
First Submitted That Met QC Criteria
January 8, 2007
First Posted (Estimate)
January 9, 2007
Study Record Updates
Last Update Posted (Estimate)
December 3, 2009
Last Update Submitted That Met QC Criteria
December 2, 2009
Last Verified
December 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Tobacco Use Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Narcotic Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Alcohol Deterrents
- Dopamine Uptake Inhibitors
- Naltrexone
- Bupropion
Other Study ID Numbers
- K01DA019446-01 (U.S. NIH Grant/Contract)
- DPMC (Other Identifier: NIDA)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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