MethamphetaminePhase 2NCT00345371
Topiramate for the Treatment of Methamphetamine Dependence - 1
A Phase 2 study testing Topiramate in people with Methamphetamine, run by National Institute on Drug Abuse (NIDA) at 8 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Methamphetamine
- What is being tested?
- Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2006to Dec 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Treatment seeking individuals as the time of the study
- Must be able to proved written informed consent
- Must have a body mass index greater than 18 kg/m(2)
- Must meet DSM-IV criteria for methamphetamine dependence
- Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
- If female of child bearing potential, must agree to use birth control
Who cannot join
- Please contact the site for more information
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
UVA CARE
Charlottesville, Virginia, 22911
Matrix Institute on Addictions
Costa Mesa, California, 92627
Powell Chemical Dependency Center
Des Moines, Iowa, 50316
John A. Burns School of Medicine
Honolulu, Hawaii, 96813
University of Missouri - Kansas City
Kansas City, Missouri, 64108
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148
South Bay Treatment Center
San Diego, California, 92105
Torrance Site
Torrance, California, 90502
About this study
Official title: Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence
The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
- Conditions
- Methamphetamine
- Being tested
- Topiramate, Placebo Oral Tablet
- Keywords
- methamphetamine addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopiramateDrug
Also called Topamax
Placebo Oral TabletDrug
| Study group | Role | What they receive |
|---|---|---|
| Topiramate | Active comparator | Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Receives: Drug: Topiramate |
| Placebo Oral Tablet | Placebo comparator | After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence (Weeks 6 - 12)
The number of participants who abstained from methamphetamine from weeks 6 through 12
Measured: weeks 6 through 12
Secondary outcomes (1)
Abstinence (Weeks 1 - 12)
Number of participants who abstained from methamphetamine from weeks 1 through 12
Measured: Weeks 1 through 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startApr 2006
- Primary completionAug 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MethamphetamineStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Bankole Johnson, Principal investigator, VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345371
- Sponsor's protocol ID
- NIDA-CSP-1025-1
- Status last verified
- Feb 2017
- First submitted
- 27 Jun 2006
- Last updated
- 27 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Elkashef A, Kahn R, Yu E, Iturriaga E, Li SH, Anderson A, Chiang N, Ait-Daoud N, Weiss D, McSherry F, Serpi T, Rawson R, Hrymoc M, Weis D, McCann M, Pham T, Stock C, Dickinson R, Campbell J, Gorodetzky C, Haning W, Carlton B, Mawhinney J, Li MD, Johnson BA. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial. Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28.
PubMed 22221594Li MD, Wang J, Niu T, Ma JZ, Seneviratne C, Ait-Daoud N, Saadvandi J, Morris R, Weiss D, Campbell J, Haning W, Mawhinney DJ, Weis D, McCann M, Stock C, Kahn R, Iturriaga E, Yu E, Elkashef A, Johnson BA. Transcriptome profiling and pathway analysis of genes expressed differentially in participants with or without a positive response to topiramate treatment for methamphetamine addiction. BMC Med Genomics. 2014 Dec 12;7:65. doi: 10.1186/s12920-014-0065-x.
PubMed 25495887
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00345371
- Acronym / sponsor ID
- NIDA-CSP-1025-1
- Conditions
- Methamphetamine
- Keywords
- methamphetamine addiction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2006
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Jun 2006 (estimated)
- Results
- Posted 23 Feb 2017
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 topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topiramate | Active comparator | Drug: TopiramateSubjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. |
| Placebo Oral Tablet | Placebo comparator | Drug: Placebo Oral TabletAfter randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Treatment seeking individuals as the time of the study
- Must be able to proved written informed consent
- Must have a body mass index greater than 18 kg/m(2)
- Must meet DSM-IV criteria for methamphetamine dependence
- Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
Key exclusion criteria (1 listed)
- Please contact the 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 |
|---|---|---|
| TopiramateAlso: Topamax | Drug | Topiramate |
| Placebo Oral Tablet | Drug | Placebo Oral Tablet |
Primary outcome
Abstinence (Weeks 6 - 12)
Time frame: weeks 6 through 12
The number of participants who abstained from methamphetamine from weeks 6 through 12
1 secondary outcome
Abstinence (Weeks 1 - 12)
Time frame: Weeks 1 through 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22221594Elkashef A, Kahn R, Yu E, Iturriaga E, Li SH, Anderson A, Chiang N, Ait-Daoud N, Weiss D, McSherry F, Serpi T, Rawson R, Hrymoc M, Weis D, McCann M, Pham T, Stock C, Dickinson R, Campbell J, Gorodetzky C, Haning W, Carlton B, Mawhinney J, Li MD, Johnson BA. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial. Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28.
- Derived from this study: PubMed 25495887Li MD, Wang J, Niu T, Ma JZ, Seneviratne C, Ait-Daoud N, Saadvandi J, Morris R, Weiss D, Campbell J, Haning W, Mawhinney DJ, Weis D, McCann M, Stock C, Kahn R, Iturriaga E, Yu E, Elkashef A, Johnson BA. Transcriptome profiling and pathway analysis of genes expressed differentially in participants with or without a positive response to topiramate treatment for methamphetamine addiction. BMC Med Genomics. 2014 Dec 12;7:65. doi: 10.1186/s12920-014-0065-x.
- Link to abstractLink provided by the sponsor.
Related trials for Methamphetamine
Active, not recruiting
Testing an Accelerated TMS Protocol for Methamphetamine Use Disorder
Methamphetamine Use Disorder
Not yet recruiting
Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy
Methamphetamine Use Disorder, Pregnancy
Recruiting
Rehabilitation Program for People With Methamphetamine-Associated Cardiopulmonary Conditions
Methamphetamine-Associated Heart Failure, Methamphetamine-Associated Pulmonary Arterial Hypertension
Not yet recruitingPhase 1
Methamphetamine Isomer Pharmacology in Humans
Methamphetamine
Not yet recruiting
Closed-loop TMS for the Core Clinical Features of Methamphetamine Use Disorder
Methamphetamine Use Disorder, Substance Use Disorder
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.
Bankole Johnson principal investigator
VA Medical Center
8 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 Topiramate in people with Methamphetamine, run by National Institute on Drug Abuse (NIDA) at 8 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 6 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 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Abstinence (Weeks 6 - 12) (time frame: weeks 6 through 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345371, which also lists 2 linked publications.
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 27 Mar 2017.