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Mindfulness Based Relapse Prevention for Stimulant Users (MBRP)

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ClinicalTrials.gov Identifier: NCT01094223
Recruitment Status : Unknown
Verified December 2015 by Suzette Glasner-Edwards, University of California, Los Angeles.
Recruitment status was:  Active, not recruiting
First Posted : March 26, 2010
Last Update Posted : December 18, 2015
Sponsor:
Information provided by (Responsible Party):
Suzette Glasner-Edwards, University of California, Los Angeles

Brief 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. 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). 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.

Condition or disease Intervention/treatment Phase
Stimulant Dependence Behavioral: Mindfulness Based Relapse Prevention Behavioral: Health Education Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mindfulness Based Relapse Prevention for Stimulant Users
Study Start Date : April 2010
Actual Primary Completion Date : April 2012
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Mindfulness Behavioral: Mindfulness Based Relapse Prevention
Meditation based therapy group incorporating relapse prevention skills training

Active Comparator: Health Education Behavioral: Health Education
Psychoeducation group focused on various topics pertaining to physical health




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. HIV Risk behaviors [ Time Frame: baseline (week 0), treatment-end (week 12), and follow up (week 24) ]
    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.



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 to 59
  2. DSM-IV diagnosis of Stimulant Dependence
  3. Able to provide informed consent
  4. Willing and able to participate in study procedures

Exclusion Criteria:

  1. 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
  2. Lack of proficiency in English
  3. Currently homeless (unless residing in a recovery home for which contact information can be provided)
  4. Dependence on an illicit substance for which medical detoxification is imminently needed.
  5. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094223


Locations
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United States, California
UCLA
Los Angeles, California, United States, 90025
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Suzette Glasner-Edwards, Ph.D. University of California, Los Angeles

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Responsible Party: Suzette Glasner-Edwards, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01094223     History of Changes
Other Study ID Numbers: MBRP1R21DA029255-01
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Suzette Glasner-Edwards, University of California, Los Angeles:
Stimulant
Addiction
Mindfulness
Treatment

Additional relevant MeSH terms:
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Central Nervous System Stimulants
Physiological Effects of Drugs