- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00572234
Bupropion in the Treatment of Methamphetamine Dependence
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Nearly 40% of adults seeking substance use disorders (SUD) treatment in Nebraska report methamphetamine is their drug of choice. In preliminary studies examining bupropion in methamphetamine use, it was well tolerated, reduced craving for methamphetamine and reduced methamphetamine related euphoria. Investigators at the University of Nebraska Medical Center and the University of Nebraska-Lincoln have initiated studies examining bupropion in animals and humans as a potential intervention in addictive disorders. Pre-clinical studies in the Co-Investigator's laboratory were the first to demonstrate the potential utility of bupropion as a pharmacotherapy for methamphetamine use disorders (MUD) while the Principal Investigator studied bupropion as a smoking cessation aid in alcoholics.
The primary goal of this study is to establish an interdisciplinary and translational collaboration to test bupropion in persons in treatment for methamphetamine dependence and to inform pre-clinical studies so as to enhance their practical applicability to clinical settings. The pilot clinical study will examine the treatment effect and safety of a 12 week course of bupropion in persons with methamphetamine use disorder. Concurrently, we will examine the efficacy of bupropion on methamphetamine self-administration in animal models which better simulates clinical approaches.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States, 68104
- Catholic Charities Campus for Hope
-
Omaha, Nebraska, United States, 68105
- Veterans Affairs Medical Center, Omaha
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patient in the substance use disorder program at either the Omaha VA Medical Center or at Catholic Charities Campus for Hope
- diagnosis of methamphetamine dependence as well as presence or history of psychosis based on the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria (not to include patients in full sustained remission)
- provide names, addresses, and phone numbers of at least two collateral informants who can provide information on their methamphetamine and other drug use during follow-up
- must sign an informed consent as approved by the UNMC Internal Review Board (IRB) and Catholic Charities Research Committee.
Exclusion Criteria:
- a history of severe injury to their brain
- advanced cardiac, pulmonary, renal or liver disease
- predisposition to seizures
- history of bulimia or anorexia nervosa
- current diagnosis of major depressive disorder
- diagnosis or past history of panic disorders, schizophrenia, or bipolar affective disorder
- family history or childhood history of epilepsy or seizures
- history of strokes, brain tumors, or bleeding in the brain.
- used any psychoactive drug within one week of study entry (two weeks for MAO (monoamine oxidase) inhibitors or protriptyline, four weeks for fluoxetine)
- currently using any theophylline product (e.g. Theodur)
- used an investigational drug in any study within the past four weeks
- used a therapeutic course of bupropion SR for > 1 week at any time in the past 12 months or have been evaluated in previous studies examining bupropion SR at anytime
- If female, the participant must not be pregnant or breast feeding
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Receiving Bupropion SR
receiving bupropion SR 12 week course of bupropion SR 150 mg, BID (twice a day)
|
12 week course of bupropion SR 150 mg, BID
|
No Intervention: Treatment as Usual
Not receiving bupropion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimate the Treatment Effect of Bupropion for Methamphetamine (Meth) Dependence.
Time Frame: Assessed Methamphetamine use at weeks 12 and 24, week 24 reported
|
The primary outcome measure was number of days methamphetamine use/week at weeks 12 and week 24.
|
Assessed Methamphetamine use at weeks 12 and 24, week 24 reported
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kathleen M Grant, MD, Veterans Affairs Medical Center, Omaha
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Dopamine Uptake Inhibitors
- Bupropion
Other Study ID Numbers
- 0260-07-FB
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.
Clinical Trials on Methamphetamine Use Disorder
-
Turning PointMonash University; Eastern Health; Deakin UniversityActive, not recruitingMethamphetamine Use DisorderAustralia
-
University of California, Los AngelesNational Institute on Drug Abuse (NIDA)Terminated
-
University of Colorado, DenverNational Institute on Drug Abuse (NIDA)Not yet recruitingMethamphetamine Use DisorderUnited States
-
Turning PointMonash University; Eastern Health; National Centre for Clinical Research on Emerging...RecruitingMethamphetamine Use DisorderAustralia
-
Shanghai Mental Health CenterWuhan Mental Health Centre; Wuhan Judicial Bureau Hanyang Compulsory Isolated...Active, not recruitingMethamphetamine Use DisorderChina
-
Glenn-Milo SantosNational Institute on Drug Abuse (NIDA)Active, not recruitingMethamphetamine Use DisorderUnited States
-
Craig RushNational Institute on Drug Abuse (NIDA)CompletedMethamphetamine Use DisorderUnited States
-
University of Texas Southwestern Medical CenterNational Institute on Drug Abuse (NIDA); The Emmes Company, LLCCompletedMethamphetamine Use DisorderUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)Active, not recruitingMethamphetamine Use Disorder | Cocaine Use Disorder | Cocaine Dependence | Methamphetamine Dependence | Stimulant Use Disorder | Methamphetamine Abuse | Cocaine Abuse | Stimulant Abuse | Stimulant UseUnited States
-
The University of Texas Health Science Center,...RecruitingMethamphetamine Use DisorderUnited States
Clinical Trials on bupropion SR
-
Orexigen Therapeutics, IncCompleted
-
National Institute on Drug Abuse (NIDA)CompletedTobacco Use Disorder | Tobacco Use CessationUnited States
-
Watching Over Mothers & Babies FoundationUniversity of ArizonaCompleted
-
National Institute on Drug Abuse (NIDA)CompletedSchizophrenia | Tobacco Use DisorderUnited States
-
James DavisAxsome Therapeutics, Inc.CompletedSmoking Cessation | Nicotine Dependence | Smoking, CigaretteUnited States
-
Orexigen Therapeutics, IncCompleted
-
Orexigen Therapeutics, IncCompletedObesity | OverweightUnited States
-
Mayo ClinicNational Cancer Institute (NCI); University of MinnesotaCompleted
-
University of Alabama at BirminghamNot yet recruiting
-
G&E Herbal Biotechnology Co., LTDCompletedActinic Keratosis | Bowen's DiseaseTaiwan