DepressionPhase 1NCT00252434
Behavioral Therapy Development for Methamphetamine Abuse
A Phase 1 study testing Cognitive Behavioral Therapy Development for Methamphetamine Abuse in people with Depression and Drug Abuse, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The purpose of this study is to evaluate whether a specially developed group counseling approach is better able to help HIV-positive gay and bisexual men (GBM) who use crystal meth to stop using methamphetamines, reduce sexual risk behaviors, and stay on their HIV medications than a standard drug treatment program. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men only
- Conditions the study is for
- Depression, Drug Abuse, Sexually Transmitted Diseases
- What is being tested?
- Cognitive Behavioral Therapy Development for Methamphetamine Abuse
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Nov 2007
- Phase
- Phase 1
- 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
- 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 University of California, Los Angeles (UCLA) Center for Clinical AIDS Research and Education (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-International Neuropsychiatric Interview (MINI)
- Interested in seeking treatment for 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 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria for current bipolar disorder or a psychotic disorder)
- Current suicidal ideation or suicide attempt within the past 3 months
- 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
1 site in 1 country.
United States1 site
UCLA Center for Clinical AIDS Research and Education (CARE) Clinic
Los Angeles, California, 90035
About this study
The purpose of this study is to evaluate whether a specially developed group counseling approach is better able to help HIV-positive gay and bisexual men (GBM) who use crystal meth to stop using methamphetamines, reduce sexual risk behaviors, and stay on their HIV medications than a standard drug treatment program. Another purpose is to determine whether having a drug abuse treatment program in an HIV medical clinic makes it easier to attend treatment than going to a separate location for drug abuse treatment.
Read the detailed description
The study features activities that include development and refinement of a culturally-specific cognitive behavioral therapy that integrates aspects of drug abuse treatment with HIV medication adherence interventions and cultural elements of being a gay or bisexual man receiving medical care for HIV/AIDS. To estimate the size of the signal of this intervention, the study proposes a two parallel group design in which 50 treatment-seeking HIV-seropositive gay and bisexual men who meet criteria for methamphetamine abuse and who receive HIV medical care at the UCLA Center for Clinical AIDS Research and Education (CARE) clinic are randomized to the study condition or a treatment-as-usual (TAU) condition. Participants assigned to the experimental condition receive 12 weeks of twice-weekly GCBT, with a 6-months post-randomization follow-up visit. Participants assigned to the TAU condition are referred to the UCLA Addiction Medicine Clinic (AMC), where they receive the clinic's standard of care treatment for methamphetamine dependence for 12 weeks, and return for a 6-month follow-up visit. Analyses are conducted on all participants who meet inclusion/exclusion criteria, express desire for treatment, and receive at least one "dose" of the cognitive-behavioral treatment or make one visit to the AMC. Participants in both conditions agree to weekly and monthly data collection visits, including the provision of urine samples. Primary outcome variables are methamphetamine use, sexual risk behaviors, and HIV medication compliance. The proposed design maintains the focus on intervention development and feasibility, while recognizing that the second phase of this development will be informed by having accurate estimates of effect sizes for the intervention and adequate resources to conduct the full-scale trial.
- Conditions
- Depression, Drug Abuse, Sexually Transmitted Diseases
- Being tested
- Cognitive Behavioral Therapy Development for Methamphetamine Abuse
- Keywords
- high-risk sexual behavior, methamphetamine use, drug craving, addiction behaviors
- Medical subject headings
- Depression, Substance-Related Disorders, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy Development for Methamphetamine AbuseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
methamphetamine use
Measured: weekly
Secondary outcomes (1)
sexual risk behaviors
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startAug 2004
- Primary completionNov 2007
- Study completionNov 2007
Why it stopped: Slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Investigators
- James A. Peck, PsyD., Principal investigator, UCLA Integrated Substance Abuse ProgramsJames A Peck, Psy.D., Principal investigator, UCLA Integrated Substance Abuse Programs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252434
- Sponsor's protocol ID
- 1R21DA018075
- Status last verified
- Jan 2016
- First submitted
- 10 Nov 2005
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Therapy Development for Methamphetamine Abuse
- ClinicalTrials.gov ID
- NCT00252434
- Acronym / sponsor ID
- 1R21DA018075
- Conditions
- Depression, Drug Abuse, Sexually Transmitted Diseases
- Keywords
- high-risk sexual behavior, methamphetamine use, drug craving, addiction behaviors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow enrollment
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Nov 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 11 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 evaluate whether a specially developed group counseling approach is better able to help HIV-positive gay and bisexual men (GBM) who use crystal meth to stop using methamphetamines, reduce sexual risk behaviors, and stay on their HIV medications than a standard drug treatment program. Another purpose is to determine whether having a drug abuse treatment program in an HIV medical clinic makes it easier to attend treatment than going to a separate location for drug abuse treatment.
Detailed description
The study features activities that include development and refinement of a culturally-specific cognitive behavioral therapy that integrates aspects of drug abuse treatment with HIV medication adherence interventions and cultural elements of being a gay or bisexual man receiving medical care for HIV/AIDS. To estimate the size of the signal of this intervention, the study proposes a two parallel group design in which 50 treatment-seeking HIV-seropositive gay and bisexual men who meet criteria for methamphetamine abuse and who receive HIV medical care at the UCLA Center for Clinical AIDS Research and Education (CARE) clinic are randomized to the study condition or a treatment-as-usual (TAU) condition. Participants assigned to the experimental condition receive 12 weeks of twice-weekly GCBT, with a 6-months post-randomization follow-up visit. Participants assigned to the TAU condition are referred to the UCLA Addiction Medicine Clinic (AMC), where they receive the clinic's standard of care treatment for methamphetamine dependence for 12 weeks, and return for a 6-month follow-up visit. Analyses are conducted on all participants who meet inclusion/exclusion criteria, express desire for treatment, and receive at least one "dose" of the cognitive-behavioral treatment or make one visit to the AMC. Participants in both conditions agree to weekly and monthly data collection visits, including the provision of urine samples. Primary outcome variables are methamphetamine use, sexual risk behaviors, and HIV medication compliance. The proposed design maintains the focus on intervention development and feasibility, while recognizing that the second phase of this development will be informed by having accurate estimates of effect sizes for the intervention and adequate resources to conduct the full-scale trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- 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 University of California, Los Angeles (UCLA) Center for Clinical AIDS Research and Education (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-International Neuropsychiatric Interview (MINI)
- Interested in seeking treatment for 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 Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision [DSM-IV-TR] criteria for current bipolar disorder or a psychotic disorder)
- Current suicidal ideation or suicide attempt within the past 3 months
- 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 |
|---|---|---|
| Cognitive Behavioral Therapy Development for Methamphetamine Abuse | Behavioural | – |
Primary outcome
methamphetamine use
Time frame: weekly
1 secondary outcome
sexual risk behaviors
Time frame: monthly
Results and safety
The study was stopped early (reason given: Slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
James A. Peck, PsyD. principal investigator
UCLA Integrated Substance Abuse Programs
James A Peck, Psy.D. principal investigator
UCLA Integrated Substance Abuse Programs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cognitive Behavioral Therapy Development for Methamphetamine Abuse in people with Depression and Drug Abuse, run by University of California, Los Angeles 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 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: stopped early, as of the sponsor's last update on 27 Jan 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 stopped early (reason given: Slow enrollment). 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?
methamphetamine use (time frame: weekly). 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 27 Jan 2016.