The Study Was Designed to Develop a Cognitive Behavioral Approach to Treating Methamphetamine Abuse in HIV Primary Care SettingsPhase 2NCT00249678
Behavioral Therapy Development for Methamphetamine Abusers
A Phase 2 study testing Behavior Therapy in people with The Study Was Designed to Develop a Cognitive Behavioral Approach to Treating Methamphetamine Abuse in HIV Primary Care Settings, run by University of California, Los Angeles at 3 sites in United States.
Trial summary
The purpose of this study is...to assess whether placing a substance abuse intervention for HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors more than treatment-as-usual; and… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- The Study Was Designed to Develop a Cognitive Behavioral Approach to Treating Methamphetamine Abuse in HIV Primary Care Settings
- What is being tested?
- Behavior Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2004to May 2007
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-seropositive, GBM receiving medical treatment for HIV for at least 30 days prior to signing informed consent at the UCLA CARE clinic, aged 18-65
- Willing to give informed consent and comply with study procedures;
- Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications;
- Diagnosed with current methamphetamine abuse as determined by MINI; and
- Interested in seeking treatment for their methamphetamine abuse and in participating in this research project.
Who cannot join
- Unwilling to give, or withdrawal of, informed consent;
- Inability to understand nature of study;
- A psychiatric condition that, in the principal investigator's judgment, warrants additional intervention to ensure participant safety (e.g., meets DSM-IV-TR criteria for current bipolar disorder or a psychotic disorder);
- Current suicidal ideation or suicide attempt within the past 3 months; and
- Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI.
- Total lack of any type of healthcare coverage. These potential participants will be given low-fee treatment referrals.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
UCLA Medical Center
Los Angeles, California, 90024
UCLA, Integrated Substance Abuse Programs
Los Angeles, California, 90024
UCLA CARE Clinic
Los Angeles, California, 90035
About this study
Official title: Behavioral Therapy Development for Methamphetamine Abuse
The purpose of this study is...to assess whether placing a substance abuse intervention for HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.
- Being tested
- Behavior Therapy
- Keywords
- Behavior Therapy, methamphetamine
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.
Craving
Medication compliance
Addiction severity
Psychiatric interview
Sex-risk behavior
Secondary outcomes (2)
Depression
Quality of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2005 (estimated)
- Study startSep 2004 (estimated)
- Primary completionMay 2007
- Study completionMay 2007
Why it stopped: Investigator left the institution before enrolling any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Study Was Designed to Develop a Cognitive Behavioral Approach to Treating Methamphetamine Abuse in HIV Primary Care SettingsStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Steve Shoptaw, University of California, Los Angeles
- Investigators
- James Peck, Other, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00249678
- Sponsor's protocol ID
- NIDA-18075-1
- Other IDs
- R21DA018075, R21-18075-1
- Status last verified
- Feb 2020
- First submitted
- 3 Nov 2005
- Last updated
- 17 Feb 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Therapy Development for Methamphetamine Abuse
- ClinicalTrials.gov ID
- NCT00249678
- Acronym / sponsor ID
- NIDA-18075-1
- Keywords
- Behavior Therapy, methamphetamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator left the institution before enrolling any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2004 (estimated)
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 7 Nov 2005 (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 whether placing a substance abuse intervention for HIV+ methamphetamine users within an HIV medical care setting improves rates of follow-up on referral to treatment by primary care physicians; reduces drug use and sexual risk behaviors more than treatment-as-usual; and increases rates of adherence to HIV medication regimens.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HIV-seropositive, GBM receiving medical treatment for HIV for at least 30 days prior to signing informed consent at the UCLA CARE clinic, aged 18-65
- Willing to give informed consent and comply with study procedures;
- Willing to provide consent to contact treating physicians and pharmacies to assess adherence to HIV medications;
- Diagnosed with current methamphetamine abuse as determined by MINI; and
- Interested in seeking treatment for their methamphetamine abuse and in participating in this research project.
Key exclusion criteria (6 listed)
- Unwilling to give, or withdrawal of, informed consent;
- Inability to understand nature of study;
- A psychiatric condition that, in the principal investigator's judgment, warrants additional intervention to ensure participant safety (e.g., meets DSM-IV-TR criteria for current bipolar disorder or a psychotic disorder);
- Current suicidal ideation or suicide attempt within the past 3 months; and
- Concurrent dependence on opiates, alcohol, or benzodiazepines as determined by MINI.
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
Craving
Medication compliance
Addiction severity
Psychiatric interview
Sex-risk behavior
2 secondary outcomes
Depression
Quality of Life
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
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.
James Peck, Other principal investigator
University of California, Los Angeles
3 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 The Study Was Designed to Develop a Cognitive Behavioral Approach to Treating Methamphetamine Abuse in HIV Primary Care Settings, run by University of California, Los Angeles at 3 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 6 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: withdrawn, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The study was withdrawn before enrolling participants, so there are no results.
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 5 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 17 Feb 2020.