Crystal Methamphetamine AbusePhase 1NCT01255280
Behavioral Activation and HIV Risk Reduction for Men Who Have Sex With Men With Crystal Meth Abuse
A Phase 1 study testing Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR) and Information, Motivation, Behavioral skills change approach to sexual risk reduction in people with Crystal Methamphetamine Abuse and Crystal Methamphetamine Dependence, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Crystal Methamphetamine Abuse, Crystal Methamphetamine Dependence
- What is being tested?
- Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR) and Information, Motivation, Behavioral skills change approach to sexual risk reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2013
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years or older
- Self-reports as a man who has sex with men
- HIV-uninfected and verifies serostatus at baseline (HIV antibody testing and positive tests will be confirmed by Western Blots; see Human Subjects for operational aspects)
- Meets DSM-IV diagnostic criteria for crystal meth abuse/dependence
- Self reported unprotected anal intercourse-receptive or insertive-with a non-monogamous male sexual partner, while concurrently using crystal meth (use of meth must be a few hours prior to, or during, sex) in the prior three months
Who cannot join
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Has lived in the greater Boston area for three months or less (as a means to enhance participant retention)
- Discovery of active suicidal ideation at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Fenway Community Health
Boston, Massachusetts, 02215
Jaclyn White, MPH, 617-927-6101, jwhite@fenwayhealth.org
About this study
Official title: Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse
The purpose of this study is to research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.
Read the detailed description
- To estimate, in a two-arm pilot randomized controlled trial (RCT), the effect size of the proposed intervention on reductions in sexual risk taking and crystal meth use. The primary outcome is the number of unprotected anal sex acts and a secondary outcome is reduction in crystal meth use episodes over the follow up period.
- To explore the degree to which improvements in sexual risk taking are associated with the conceptual mediators of the effects of the intervention: reductions in crystal meth use and increases in pleasurable (but safe) activities, BAT skills, use of risk reduction skills, and reductions in depressed mood.
- Being tested
- Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR), Information, Motivation, Behavioral skills change approach to sexual risk reduction
- Keywords
- Crystal methamphetamine abuse, Crystal methamphetamine dependence, Sexual risk behavior, Men who have sex with men (MSM), Behavioral activation
- Medical subject headings
- Homosexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)Behavioural
This intervention is given to patients in the experimental condition only and is comprised of 10 sessions.
Information, Motivation, Behavioral skills change approach to sexual risk reductionBehavioural
The comparison condition will only receive the two IMB risk reduction sessions.
| Study group | Role | What they receive |
|---|---|---|
| Information, Motivation, Behavioral skills | Active comparator | The comparison condition will only receive the two IMB risk reduction sessions. The intervention will begin with modules that focus directly with sexual risk reduction practices. It will begin with a discussion of one's sexual history, sexual risk limits, and barriers (e.g., motivation or skills) to staying in their sexual risk limits. This session will also involve a Q\&A discussion and the use of a fact sheet regarding HIV acquisition risk behaviors (information). The next session will involve motivational interviewing and the formulation of an individualized behavioral skills plan as needed. Receives: Behavioral: Information, Motivation, Behavioral skills change approach to sexual risk reduction |
| Behavioral Activation Therapy and Risk Reduction Counseling | Experimental | This intervention is given to patients in the experimental condition only and is comprised of 10 sessions-1 baseline session focused on orienting and rationale, 2 focused on risk reduction (consistent with the IMB model: information, motivation, and behavioral skills), 6 incorporating behavioral activation therapy/risk reduction counseling, and 1 final session on relapse prevention. Each session will last approximately fifty minutes in length; and will also involve a review of the previous materials,and hence the behavioral activation approach will be woven back into the risk reduction content. Receives: Behavioral: Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sexual risk
We will ask about number of unprotected and protected insertive and receptive anal, vaginal and oral sex acts with male and female sex partners separately for HIV seropositive, seronegative, and partners of unknown HIV status with questions from measures used in previous studies. We will use this to calculate the ratio of protected to unprotected acts, by serostatus partner, and by whether or not crystal meth was being used before or during sex. Baseline and three and six-month follow-up assessments will assess sexual risk taking in the previous 3-months to the assessment being completed.
Measured: Baseline and three months post-treatment; baseline and six months post-treatment
Secondary outcomes (1)
Change in crystal methamphetamine use
For the present study, we will administer relevant sections of the Drug and Alcohol sections of the NIDA-CTN Addictions Severity Index Lite (ASI-Lite). We will use this methodology to determine the number of days of drug use, specifically crystal meth, and the number of distinct crystal meth episodes between study assessment visits (i.e., separate crystal meth binges).In addition to the ASI-Lite, we will also collect participant self-report measures of substance use via the ACASI. We have adapted and will also use the CDC's National HIV Behavioral Surveillance Survey, MSM cycle.
Measured: Baseline and three months post-treatment; baseline and six months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crystal Methamphetamine AbuseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fenway Community Health
- Responsible party
- Principal investigator, Matthew James Mimiaga, Massachusetts General Hospital
- Investigators
- Matthew Mimiaga, ScD, Principal investigator, Fenway Community Health and Massachusetts General Hospital/Harvard Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01255280
- Sponsor's protocol ID
- 3293841
- Status last verified
- May 2012
- First submitted
- 3 Dec 2010
- Last updated
- 1 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rajasingham R, Mimiaga MJ, White JM, Pinkston MM, Baden RP, Mitty JA. A systematic review of behavioral and treatment outcome studies among HIV-infected men who have sex with men who abuse crystal methamphetamine. AIDS Patient Care STDS. 2012 Jan;26(1):36-52. doi: 10.1089/apc.2011.0153. Epub 2011 Nov 9.
PubMed 22070609
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation and HIV Risk Reduction for MSM With Crystal Methamphetamine Abuse
- ClinicalTrials.gov ID
- NCT01255280
- Acronym / sponsor ID
- 3293841
- Keywords
- Crystal methamphetamine abuse, Crystal methamphetamine dependence, Sexual risk behavior, Men who have sex with men (MSM), Behavioral activation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Fenway Community Health
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 7 Dec 2010 (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 research a new behavioral treatment to reduce sexual risk-taking in men who have sex with men (MSM) who abuse crystal methamphetamine (crystal meth), and are at risk for HIV acquisition. This study proposes using a treatment based on our original pilot study that incorporates risk reduction and behavioral activation therapy. In order to help learn what types of treatment programs best help individuals who abuse crystal meth and engage in sexual risk-taking, we will compare our treatment to a control group. The treatment group will receive therapy incorporating behavioral risk reduction counseling with behavioral activation therapy to treat depression, helping individuals reengage in their life. The control group will receive the risk reduction counseling without the behavioral activation therapy. The current study hopes to explore the efficacy of this previous developed treatment in a two-arm pilot randomized controlled trial.
Detailed description
- To estimate, in a two-arm pilot randomized controlled trial (RCT), the effect size of the proposed intervention on reductions in sexual risk taking and crystal meth use. The primary outcome is the number of unprotected anal sex acts and a secondary outcome is reduction in crystal meth use episodes over the follow up period.
- To explore the degree to which improvements in sexual risk taking are associated with the conceptual mediators of the effects of the intervention: reductions in crystal meth use and increases in pleasurable (but safe) activities, BAT skills, use of risk reduction skills, and reductions in depressed mood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Information, Motivation, Behavioral skills | Active comparator | Behavioral: Information, Motivation, Behavioral skills change approach to sexual risk reductionThe comparison condition will only receive the two IMB risk reduction sessions. The intervention will begin with modules that focus directly with sexual risk reduction practices. It will begin with a discussion of one's sexual history, sexual risk limits, and barriers (e.g., motivation or skills) to staying in their sexual risk limits. This session will also involve a Q\&A discussion and the use of a fact sheet regarding HIV acquisition risk behaviors (information). The next session will involve motivational interviewing and the formulation of an individualized behavioral skills plan as needed. |
| Behavioral Activation Therapy and Risk Reduction Counseling | Experimental | Behavioral: Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)This intervention is given to patients in the experimental condition only and is comprised of 10 sessions-1 baseline session focused on orienting and rationale, 2 focused on risk reduction (consistent with the IMB model: information, motivation, and behavioral skills), 6 incorporating behavioral activation therapy/risk reduction counseling, and 1 final session on relapse prevention. Each session will last approximately fifty minutes in length; and will also involve a review of the previous materials,and hence the behavioral activation approach will be woven back into the risk reduction content. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age: 18 years or older
- Self-reports as a man who has sex with men
- HIV-uninfected and verifies serostatus at baseline (HIV antibody testing and positive tests will be confirmed by Western Blots; see Human Subjects for operational aspects)
- Meets DSM-IV diagnostic criteria for crystal meth abuse/dependence
- Self reported unprotected anal intercourse-receptive or insertive-with a non-monogamous male sexual partner, while concurrently using crystal meth (use of meth must be a few hours prior to, or during, sex) in the prior three months
Key exclusion criteria (3 listed)
- Unable to provide informed consent due to severe mental or physical illness, or substance intoxication at the time of interview
- Has lived in the greater Boston area for three months or less (as a means to enhance participant retention)
- Discovery of active suicidal ideation at the time of interview (these patients will be referred immediately for treatment, but may join the study when this is resolved)
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 |
|---|---|---|
| Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)This intervention is given to patients in the experimental condition only and is comprised of 10 sessions. | Behavioural | Behavioral Activation Therapy and Risk Reduction Counseling |
| Information, Motivation, Behavioral skills change approach to sexual risk reductionThe comparison condition will only receive the two IMB risk reduction sessions. | Behavioural | Information, Motivation, Behavioral skills |
Primary outcome
Change in sexual risk
Time frame: Baseline and three months post-treatment; baseline and six months post-treatment
We will ask about number of unprotected and protected insertive and receptive anal, vaginal and oral sex acts with male and female sex partners separately for HIV seropositive, seronegative, and partners of unknown HIV status with questions from measures used in previous studies. We will use this to calculate the ratio of protected to unprotected acts, by serostatus partner, and by whether or not crystal meth was being used before or during sex. Baseline and three and six-month follow-up assessments will assess sexual risk taking in the previous 3-months to the assessment being completed.
1 secondary outcome
Change in crystal methamphetamine use
Time frame: Baseline and three months post-treatment; baseline and six months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2012.
- Background: PubMed 22070609Rajasingham R, Mimiaga MJ, White JM, Pinkston MM, Baden RP, Mitty JA. A systematic review of behavioral and treatment outcome studies among HIV-infected men who have sex with men who abuse crystal methamphetamine. AIDS Patient Care STDS. 2012 Jan;26(1):36-52. doi: 10.1089/apc.2011.0153. Epub 2011 Nov 9.
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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.
Matthew Mimiaga, ScD principal investigator
Fenway Community Health and Massachusetts General Hospital/Harvard Medical School
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 Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR) and Information, Motivation, Behavioral skills change approach to sexual risk reduction in people with Crystal Methamphetamine Abuse and Crystal Methamphetamine Dependence, run by Massachusetts General Hospital 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 3 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 1 Jun 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthew Mimiaga, ScD, MPH (617-927-6084, MMimiaga@fenwayhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in sexual risk (time frame: Baseline and three months post-treatment; baseline and six months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01255280, which also lists 1 linked publication.
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 1 Jun 2012.