Substance-Related DisordersPhase 2NCT00033124
A Behavioral Trial for the Treatment of Methamphetamine Dependence. - 1
A Phase 2 study testing Behavior Therapy in people with Substance-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 examine behavioral treatment for methamphetamine dependence. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Substance-Related Disorders
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2001to Jun 2002
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female at least 18 yrs of age; DSM-4 diagnosis of methamphetamine (METH) dependence; be willing to comply with study procedures; verbalize understanding of consent and provide written consent and willingness to complete study procedures; be seeking treatment for METH dependence.
Who cannot join
- Additional criteria available during screening at the site.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
South Bay Treatment Center
Chula Vista, California, 91911
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
Comprehensive Mental Health Services, Inc
Independence, Missouri, 64052
About this study
Official title: Behavioral Trial for the Treatment of Methamphetamine Dependence
The purpose of this study is to examine behavioral treatment for methamphetamine dependence.
Read the detailed description
To characterize meth. withdrawal symptoms using a multidimensional withdrawal questionnaire; to field test and investigate the effect of using an algorithm developed for discriminating between new use and residual carry-over of meth metabolites in urine and to evaluate the treatment response of meth. users to participation in the thrice weekly psychosocial protocol to be used as a "platform" in future pharmacotherapy trials.
- Conditions
- Substance-Related Disorders
- Being tested
- Behavior Therapy
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavior TherapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal symptoms
New Use algorithm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2002 (estimated)
- Study startJul 2001
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance-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
- Enrolment
- 50 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, National Institute on Drug Abuse (NIDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00033124
- Sponsor's protocol ID
- NIDA-CTO-0009-1
- Status last verified
- Aug 2003
- First submitted
- 5 Apr 2002
- Last updated
- 11 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Trial for the Treatment of Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT00033124
- Acronym / sponsor ID
- NIDA-CTO-0009-1
- Conditions
- Substance-Related Disorders
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Jul 2001
- Study completion
- Jun 2002
- First posted
- 8 Apr 2002 (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 examine behavioral treatment for methamphetamine dependence.
Detailed description
To characterize meth. withdrawal symptoms using a multidimensional withdrawal questionnaire; to field test and investigate the effect of using an algorithm developed for discriminating between new use and residual carry-over of meth metabolites in urine and to evaluate the treatment response of meth. users to participation in the thrice weekly psychosocial protocol to be used as a "platform" in future pharmacotherapy trials.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or Female at least 18 yrs of age; DSM-4 diagnosis of methamphetamine (METH) dependence; be willing to comply with study procedures; verbalize understanding of consent and provide written consent and willingness to complete study procedures; be seeking treatment for METH dependence.
Key exclusion criteria (1 listed)
- Additional criteria available during screening at the site.
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 |
|---|---|---|
| Behavior Therapy | Behavioural | – |
Primary outcome
Withdrawal symptoms
New Use algorithm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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
National Institute on Drug Abuse (NIDA)
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 Behavior Therapy in people with Substance-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 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: status not confirmed, as of the sponsor's last update on 11 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?
Results are not available in the source record.
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?
Withdrawal symptoms. 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 11 Jan 2017.