Methamphetamine DependencePhase 2NCT00520286
Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence
A Phase 2 study testing Modafinil in people with Methamphetamine Dependence, run by National Institute on Drug Abuse (NIDA) at 8 sites in United States.
Trial summary
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Methamphetamine Dependence
- What is being tested?
- Modafinil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2007to Mar 2010
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be between the ages of 18 and 65
- Methamphetamine dependent as defined by DSM-IV criteria
- Must be in good general heath with a history of methamphetamine use at screening
- Must be able to provide written informed consent
- If female and of child bearing potential, must agree to use birth control.
Who cannot join
- Please contact site for more information
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Colorado Health Sciences Center
Denver, Colorado, 80220
Powell Chemical Dependency Center
Des Moines, Iowa, 50316
John A. Burns School of Medicine
Honolulu, Hawaii, 96813
START Research and Treatment
Kansas City, Missouri, 64131
Salt Lake City VA Medical Center
Salt Lake City, Utah, 84148
South Bay Treatment Center
San Diego, California, 92105
Matrix Institute on Addictions
Tarzana, California, 91356
Torrance Site
Torrance, California, 90502
About this study
Official title: Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence
The purpose of this study will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
Read the detailed description
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.
- Conditions
- Methamphetamine Dependence
- Being tested
- Modafinil, Placebo
- Keywords
- Methamphetamine Dependence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ModafinilDrug
200 mg or 400 mg /daily
PlaceboDrug
Placebo / daily
| Study group | Role | What they receive |
|---|---|---|
| Modafinil | Active comparator | Participants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks Receives: Drug: Modafinil |
| Placebo | Placebo comparator | Participants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence (Week 1 - 12)
Number of participant who abstained from methamphetamine from weeks 1 through 12
Measured: Weeks 1 - 12
Secondary outcomes (1)
Reduction of Craving
Number of subjects with 21 or more consecutive days of abstinence
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2007 (estimated)
- Study startDec 2007
- Primary completionDec 2009
- Study completionMar 2010
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 (1)Papers the sponsor has linked to this study.
- Other trials for Methamphetamine DependenceStudies 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
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
- Investigators
- Ahmed Elkashef, M.D., Principal investigator, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520286
- Sponsor's protocol ID
- NIDA-CSP-1026-1
- Status last verified
- Feb 2017
- First submitted
- 23 Aug 2007
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):135-41. doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12.
PubMed 21840138
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase2, Double-blind, Placebo-controlled Trial of Modafinil for the Treatment of Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00520286
- Acronym / sponsor ID
- NIDA-CSP-1026-1
- Conditions
- Methamphetamine Dependence
- Keywords
- Methamphetamine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- VA Office of Research and Development
- Study start
- Dec 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 24 Aug 2007 (estimated)
- Results
- Posted 7 Apr 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 will be to examine the safety and efficacy of modafinil in increasing number of methamphetamine non-use weeks in subjects with methamphetamine dependence.
Detailed description
To evaluate the efficacy and safety of modafinil in reducing methamphetamine use in subjects with methamphetamine dependence. It is hypothesized that modafinil, compared to placebo, will be associated with an increase in the number of methamphetamine non-use weeks over time as measured by quantitative urine analysis for methamphetamine.
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 |
|---|---|---|
| Modafinil | Active comparator | Drug: ModafinilParticipants will receive a Modafinil 200 mg or 400 mg tablet one time per day for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a matching Modafinil placebo 200 mg or 400 mg tablet one time per day for 12 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Must be between the ages of 18 and 65
- Methamphetamine dependent as defined by DSM-IV criteria
- Must be in good general heath with a history of methamphetamine use at screening
- Must be able to provide written informed consent
- If female and of child bearing potential, must agree to use birth control.
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 |
|---|---|---|
| Modafinil200 mg or 400 mg /daily | Drug | Modafinil |
| PlaceboPlacebo / daily | Drug | Placebo |
Primary outcome
Abstinence (Week 1 - 12)
Time frame: Weeks 1 - 12
Number of participant who abstained from methamphetamine from weeks 1 through 12
1 secondary outcome
Reduction of Craving
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21840138Anderson AL, Li SH, Biswas K, McSherry F, Holmes T, Iturriaga E, Kahn R, Chiang N, Beresford T, Campbell J, Haning W, Mawhinney J, McCann M, Rawson R, Stock C, Weis D, Yu E, Elkashef AM. Modafinil for the treatment of methamphetamine dependence. Drug Alcohol Depend. 2012 Jan 1;120(1-3):135-41. doi: 10.1016/j.drugalcdep.2011.07.007. Epub 2011 Aug 12.
- Individual participant dataSharing planned: No
Related trials for Methamphetamine Dependence
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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.
Ahmed Elkashef, M.D. principal investigator
National Institute on Drug Abuse (NIDA)
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 Modafinil in people with Methamphetamine Dependence, 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 5 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 7 Apr 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 7 Apr 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 (Week 1 - 12) (time frame: Weeks 1 - 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 NCT00520286, which also lists 1 linked publication.
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 7 Apr 2017.