Amphetamine-Related DisordersPhase 2NCT00069251
Bupropion for the Treatment of Methamphetamine Dependence - 1
A Phase 2 study testing Bupropion in people with Amphetamine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 5 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- Bupropion
- How many people
- 150 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2003to Jun 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis
- Subject must be willing to comply with study procedures.
- Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures
- Be able to comply with protocol requirements
Who cannot join
- Please contact site for more information.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Matrix Institute on Addictions
Costa Mesa, California, 92627
Powell Chemical Dependency Center
Des Moines, Iowa, 50316
Pacific Addiction Research Center
Honolulu, Hawaii, 96813
University of Missouri - Kansas City
Kansas City, Missouri, 64108
South Bay Treatment Center
San Diego, California, 92105
About this study
Official title: Bupropion for the Treatment of Methamphetamine Dependence
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence
Read the detailed description
A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Bupropion
- Keywords
- amphetamine dependence
- Medical subject headings
- Amphetamine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupropionDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity addiction
Methamphetamine use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2003 (estimated)
- Study startJul 2003
- Study completionJun 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Richard Rawson, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069251
- Sponsor's protocol ID
- NIDA-CTO-0008-1
- Status last verified
- Jul 2008
- First submitted
- 18 Sep 2003
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupropion for the Treatment of Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00069251
- Acronym / sponsor ID
- NIDA-CTO-0008-1
- Conditions
- Amphetamine-Related Disorders
- Keywords
- amphetamine dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jul 2003
- Study completion
- Jun 2005
- First posted
- 24 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence
Detailed description
A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis
- Subject must be willing to comply with study procedures.
- Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures
- Be able to comply with protocol requirements
Key exclusion criteria (1 listed)
- Please contact site for more information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion | Drug | – |
Primary outcome
Severity addiction
Methamphetamine use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Rawson, Ph.D. principal investigator
University of California, Los Angeles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupropion in people with Amphetamine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity addiction. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.