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Mindfulness Based Relapse Prevention for Stimulant Users (MBRP)

Primary Purpose

Stimulant Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Relapse Prevention
Health Education
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stimulant Dependence focused on measuring Stimulant, Addiction, Mindfulness, Treatment

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness

Health Education

Arm Description

Mindfulness Based Relapse Prevention (MBRP). Meditation based therapy group incorporating relapse prevention skills training.

Health education, psychoeducation group focused on various topics pertaining to physical health

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 25, 2010
Last Updated
April 22, 2022
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT01094223
Brief Title
Mindfulness Based Relapse Prevention for Stimulant Users
Acronym
MBRP
Official Title
Mindfulness Based Relapse Prevention for Stimulant Users
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stimulant Dependence
Keywords
Stimulant, Addiction, Mindfulness, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness
Arm Type
Experimental
Arm Description
Mindfulness Based Relapse Prevention (MBRP). Meditation based therapy group incorporating relapse prevention skills training.
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Health education, psychoeducation group focused on various topics pertaining to physical health
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Relapse Prevention
Intervention Description
Meditation based therapy group incorporating relapse prevention skills training
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Psychoeducation group focused on various topics pertaining to physical health
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
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.
Time Frame
baseline (week 0), weekly during treatment (weeks 1-12), and at follow-up (week 24)
Secondary Outcome Measure Information:
Title
HIV Risk behaviors
Description
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.
Time Frame
baseline (week 0), treatment-end (week 12), and follow up (week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 to 59 DSM-IV diagnosis of Stimulant Dependence Able to provide informed consent Willing and able to participate in study procedures Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzette Glasner, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States

12. IPD Sharing Statement

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Mindfulness Based Relapse Prevention for Stimulant Users

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