Methamphetamine AddictionPhase 21DNCT00630682
A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
A Phase 2 study testing Dextroamphetamine in people with Methamphetamine Addiction, run by California Pacific Medical Center Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Methamphetamine Addiction
- What is being tested?
- Dextroamphetamine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2011
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-50 yrs. old
Who cannot join
- pregnant or lactating females
- Contact site for additional information
Trial locations and contacts
1 site in 1 country.
United States1 site
CPMC-St. Luke's Campus-Addiction Pharmacology Research Laboratory
San Francisco, California, 94110
About this study
The purpose of this study is to assess the safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.
- Conditions
- Methamphetamine Addiction
- Being tested
- Dextroamphetamine, Placebo
- Keywords
- Methamphetamine, Drug Abuse, Drug Treatment, Addiction, Meth, Treatment for Methamphetamine Dependence
- Medical subject headings
- Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DextroamphetamineDrug
1 week placebo and 8 weeks 60mg d-AMP QD.
PlaceboDrug
9 weeks of placebo 60mg capsules QD.
| Study group | Role | What they receive |
|---|---|---|
| Dextroamphetamine | Active comparator | Active drug Receives: Drug: Dextroamphetamine |
| Placebo | Placebo comparator | Placebo of drug Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)
Measured: Twice per week for 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2008 (estimated)
- Study startSep 2006
- Primary completionMar 2009
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Methamphetamine AddictionStudies 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, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
- Investigators
- Gantt Galloway, PharmD, Principal investigator, Addiction Pharmacology Research Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630682
- Sponsor's protocol ID
- 25.139
- Other IDs
- P50DA018179
- Acronym
- 1D
- Status last verified
- May 2013
- First submitted
- 28 Feb 2008
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Dextroamphetamine for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00630682
- Acronym / sponsor ID
- 1D / 25.139
- Conditions
- Methamphetamine Addiction
- Keywords
- Methamphetamine, Drug Abuse, Drug Treatment, Addiction, Meth, Treatment for Methamphetamine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 7 Mar 2008 (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 safety and effectiveness dextroamphetamine to help methamphetamine users quit or cut down on their use. The study lasts for 9 weeks. Eligible participants will attend research visits twice per week, and will receive individual counseling sessions once per week for all 9 weeks. 50% of the participants will receive the active medication while the other 50% will receive the placebo (sugar pill). Neither the participant or the study team will know if the participant is receiving the placebo or active drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextroamphetamine | Active comparator | Drug: DextroamphetamineActive drug |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of drug |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-50 yrs. old
Key exclusion criteria (2 listed)
- pregnant or lactating females
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 |
|---|---|---|
| Dextroamphetamine1 week placebo and 8 weeks 60mg d-AMP QD. | Drug | Dextroamphetamine |
| Placebo9 weeks of placebo 60mg capsules QD. | Drug | Placebo |
Primary outcome
Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure)
Time frame: Twice per week for 8 weeks
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 3 Jun 2013.
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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.
Gantt Galloway, PharmD principal investigator
Addiction Pharmacology Research Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dextroamphetamine in people with Methamphetamine Addiction, run by California Pacific Medical Center Research Institute at 1 site 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 1 inclusion and 2 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 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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?
Subjects treated with dextroamphetamine will have better outcomes than subjects treated with placebo, as indicated by the number of urine samples that do not indicate new use of MA (the primary outcome measure) (time frame: Twice per week for 8 weeks). 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 3 Jun 2013.