Amphetamine-Related DisordersPhase 2NCT00000322
Tyrosine for Methamphetamine Dependence - 1
A Phase 2 study testing Tyrosine in people with Amphetamine-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment, and craving." 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?
- Tyrosine
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 1997to Dec 2001
- 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
- 18-65 years of age. Able to provide informed consent. Desire to reduce/eliminate methamphetamine use. Used within the past two weeks. Meet DSM criteria for methamphetamine dependence.
Who cannot join
- No dependence (within the past 12 months) for other durgs except nicotine. No history or family history of tyrosine intolerance.
Trial locations and contacts
1 site in 1 country.
United States1 site
Haight Ashbury Free Clinics
San Francisco, California, 94117
About this study
Official title: Tyrosine for Methamphetamine Dependence
The purpose of this study is to evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment, and craving."
Read the detailed description
Evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment and craving.
- Conditions
- Amphetamine-Related Disorders
- Being tested
- Tyrosine
- 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.
TyrosineBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Craving
Drug use
Retention
Functioning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 1999 (estimated)
- Study startApr 1997
- Study completionDec 2001
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
- Masking
- Double blind
- Enrolment
- 89 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Investigators
- Gantt Galloway, Pharm.D., Principal investigator, Haight Ashbury Free Clinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00000322
- Sponsor's protocol ID
- NIDA-10739-1
- Other IDs
- R01-10739-1
- Status last verified
- Apr 1997
- First submitted
- 20 Sep 1999
- 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
- Tyrosine for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00000322
- Acronym / sponsor ID
- NIDA-10739-1
- Conditions
- Amphetamine-Related Disorders
- Keywords
- amphetamine dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 1997
- Study completion
- Dec 2001
- First posted
- 21 Sep 1999 (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 evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment, and craving."
Detailed description
Evaluate efficacy of tyrosine as a treatment for methamphetamine dependence in an outpatient treatment setting providing group psychosocial interventions. Examine effect of tyrosine on abstinence, retention in treatment and craving.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- 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 (1 listed)
- 18-65 years of age. Able to provide informed consent. Desire to reduce/eliminate methamphetamine use. Used within the past two weeks. Meet DSM criteria for methamphetamine dependence.
Key exclusion criteria (1 listed)
- No dependence (within the past 12 months) for other durgs except nicotine. No history or family history of tyrosine intolerance.
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 |
|---|---|---|
| Tyrosine | Behavioural | – |
Primary outcome
Craving
Drug use
Retention
Functioning
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.
Related trials for Amphetamine-Related Disorders
RecruitingPhase 2
MDMA-Assisted Therapy for Veterans With Moderate to Severe Post Traumatic Stress Disorder
Post Traumatic Stress Disorder
Not yet recruitingPhase 2
Psilocybin Therapy for Methamphetamine Use Disorder and HIV
Methamphetamine Use Disorder, Human Immunodeficiency Virus (HIV)
Recruiting
Applying Low-Intensity Focused Ultrasound in Treating Severe Substance Use Disorder: Tolerability and Effectiveness
Opioid Use Disorder, Severe, Amphetamine Use Disorder
RecruitingPhase 2
Efficacy and Safety of Sustained-release Dexamphetamine in Patients With Moderate to Severe Cocaine Use Disorder
Cocaine Use Disorder
Active, not recruitingPhase 1/2
Psilocybin-Enhanced Psychotherapy for Methamphetamine Use Disorder
Amphetamine-Related Disorders
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, Pharm.D. principal investigator
Haight Ashbury Free Clinics
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 Tyrosine in people with Amphetamine-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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 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 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. 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?
Craving. The study lists 4 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.