Stimulant DependenceMBRPNCT01094223
Mindfulness Based Relapse Prevention for Stimulant Users
A study testing Mindfulness Based Relapse Prevention and Health Education in people with Stimulant Dependence, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The broad, long-term objective of the current research is to improve treatment for stimulant use disorders by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Stimulant Dependence
- What is being tested?
- Mindfulness Based Relapse Prevention and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Dec 2012
- Phase
- Interventional
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 59
- DSM-IV diagnosis of Stimulant Dependence
- Able to provide informed consent
- Willing and able to participate in study procedures
Who cannot join
- Presence of life threatening or unstable medical illness, such as acute pulmonary, cardiovascular, or musculoskeletal disease, that would require treatment or make study participation difficult
- Lack of proficiency in English
- Currently homeless (unless residing in a recovery home for which contact information can be provided)
- Dependence on an illicit substance for which medical detoxification is imminently needed.
- Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis or acute mania, that would require ongoing treatment or make study compliance difficult.
Trial locations and contacts
1 site in 1 country.
About this study
The broad, long-term objective of the current research is to improve treatment for stimulant use disorders by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based Cognitive Therapy for depression (Segal, Teasdale, \& Williams, 2002), Marlatt and colleagues recently developed a manualized intervention for the treatment of substance using populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of MBRP relative to a health education (ED) control group in stimulant users receiving contingency management (CM).
Read the detailed description
Both MBRP and ED participants will be assessed at baseline, treatment-end, and 1 month post-treatment. 2) To test the impact of MBRP compared to ED on negative affect, stimulant use, and health care outcomes. 3) To evaluate the differential effects of MBRP versus ED on HIV-risk behavior of participants, and 4) To examine potential mechanisms of action of MBRP, including reductions in stress reactivity and biological indicators of arousal such as blood pressure and heart rate. The investigators hypothesize that MBRP will be more efficacious than ED in reducing negative affect and stimulant use. Further, the investigators expect that MBRP will produce greater reductions in HIV-risk behaviors, stress reactivity, and arousal, and these changes will be associated with substance use outcomes. MBRP incorporates specific substance-focused cognitive therapy techniques with an additional emphasis on mindfulness skills. By providing coping skills to address affect regulation and stress reactivity, two important factors in stimulant relapse, MBRP may provide a promising augmenting strategy for the treatment of stimulant users.
- Conditions
- Stimulant Dependence
- Being tested
- Mindfulness Based Relapse Prevention, Health Education
- Keywords
- Stimulant, Addiction, Mindfulness, Treatment
- Medical subject headings
- Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based Relapse PreventionBehavioural
Meditation based therapy group incorporating relapse prevention skills training
Health EducationBehavioural
Psychoeducation group focused on various topics pertaining to physical health
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness | Experimental | Mindfulness Based Relapse Prevention (MBRP). Meditation based therapy group incorporating relapse prevention skills training. Receives: Behavioral: Mindfulness Based Relapse Prevention |
| Health Education | Active comparator | Health education, psychoeducation group focused on various topics pertaining to physical health Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
The Beck Depression Inventory (BDI), a well validated self-report measure (Beck, 1967) will be administered at baseline, weekly during treatment, and at follow-up. Both the absolute total scores and change scores will be used for analyses.
Measured: baseline (week 0), weekly during treatment (weeks 1-12), and at follow-up (week 24)
Secondary outcomes (1)
HIV Risk behaviors
The HIV Risk Assessment Battery (Navaline et al., 1994) will be administered at baseline, treatment-end, and FU to assess the impact of the interventions on changes in HIV/AIDS-related risk behaviors.
Measured: baseline (week 0), treatment-end (week 12), and follow up (week 24)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stimulant DependenceStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzette Glasner-Edwards, University of California, Los Angeles
- Investigators
- Suzette Glasner, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094223
- Sponsor's protocol ID
- MBRP1R21DA029255-01
- Acronym
- MBRP
- Status last verified
- Apr 2022
- First submitted
- 25 Mar 2010
- Last updated
- 29 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Based Relapse Prevention for Stimulant Users
- ClinicalTrials.gov ID
- NCT01094223
- Acronym / sponsor ID
- MBRP / MBRP1R21DA029255-01
- Conditions
- Stimulant Dependence
- Keywords
- Stimulant, Addiction, Mindfulness, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Mar 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 broad, long-term objective of the current research is to improve treatment for stimulant use disorders by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based Cognitive Therapy for depression (Segal, Teasdale, \& Williams, 2002), Marlatt and colleagues recently developed a manualized intervention for the treatment of substance using populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of MBRP relative to a health education (ED) control group in stimulant users receiving contingency management (CM).
Detailed description
Both MBRP and ED participants will be assessed at baseline, treatment-end, and 1 month post-treatment. 2) To test the impact of MBRP compared to ED on negative affect, stimulant use, and health care outcomes. 3) To evaluate the differential effects of MBRP versus ED on HIV-risk behavior of participants, and 4) To examine potential mechanisms of action of MBRP, including reductions in stress reactivity and biological indicators of arousal such as blood pressure and heart rate. The investigators hypothesize that MBRP will be more efficacious than ED in reducing negative affect and stimulant use. Further, the investigators expect that MBRP will produce greater reductions in HIV-risk behaviors, stress reactivity, and arousal, and these changes will be associated with substance use outcomes. MBRP incorporates specific substance-focused cognitive therapy techniques with an additional emphasis on mindfulness skills. By providing coping skills to address affect regulation and stress reactivity, two important factors in stimulant relapse, MBRP may provide a promising augmenting strategy for the treatment of stimulant users.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness | Experimental | Behavioral: Mindfulness Based Relapse PreventionMindfulness Based Relapse Prevention (MBRP). Meditation based therapy group incorporating relapse prevention skills training. |
| Health Education | Active comparator | Behavioral: Health EducationHealth education, psychoeducation group focused on various topics pertaining to physical health |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18 to 59
- DSM-IV diagnosis of Stimulant Dependence
- Able to provide informed consent
- Willing and able to participate in study procedures
Key exclusion criteria (5 listed)
- Presence of life threatening or unstable medical illness, such as acute pulmonary, cardiovascular, or musculoskeletal disease, that would require treatment or make study participation difficult
- Lack of proficiency in English
- Currently homeless (unless residing in a recovery home for which contact information can be provided)
- Dependence on an illicit substance for which medical detoxification is imminently needed.
- Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis or acute mania, that would require ongoing treatment or make study compliance difficult.
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 |
|---|---|---|
| Mindfulness Based Relapse PreventionMeditation based therapy group incorporating relapse prevention skills training | Behavioural | Mindfulness |
| Health EducationPsychoeducation group focused on various topics pertaining to physical health | Behavioural | Health Education |
Primary outcome
Depressive symptoms
Time frame: baseline (week 0), weekly during treatment (weeks 1-12), and at follow-up (week 24)
The Beck Depression Inventory (BDI), a well validated self-report measure (Beck, 1967) will be administered at baseline, weekly during treatment, and at follow-up. Both the absolute total scores and change scores will be used for analyses.
1 secondary outcome
HIV Risk behaviors
Time frame: baseline (week 0), treatment-end (week 12), and follow up (week 24)
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 29 Apr 2022.
Related trials for Stimulant Dependence
Recruiting
rTMS for Craving in Methamphetamine Use Disorder
Methamphetamine Abuse, Substance Use Disorders
RecruitingPhase 2
Feasibility of Long-term, High-dose Stimulant for Methamphetamine Use Disorder
Methamphetamine Abuse, Methamphetamine-dependence
RecruitingPhase 2
Clinical Trial of High Dose Lisdexamfetamine and Contingency Management in MA Users
Methamphetamine Abuse, Methamphetamine-dependence
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.
Suzette Glasner, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Relapse Prevention and Health Education in people with Stimulant Dependence, 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 4 inclusion and 5 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 29 Apr 2022. 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.
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?
Depressive symptoms (time frame: baseline (week 0), weekly during treatment (weeks 1-12), and at follow-up (week 24)). 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 29 Apr 2022.