This trial is active, not recruiting.

Condition stimulant dependence
Treatments mindfulness based relapse prevention, health education
Sponsor University of California, Los Angeles
Start date April 2010
End date April 2012
Trial size 60 participants
Trial identifier NCT01094223, MBRP1R21DA029255-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
mindfulness based relapse prevention
Meditation based therapy group incorporating relapse prevention skills training
(Active Comparator)
health education
Psychoeducation group focused on various topics pertaining to physical health

Primary Outcomes

Depressive symptoms
time frame: baseline (week 0), weekly during treatment (weeks 1-12), and at follow-up (week 24)

Secondary Outcomes

HIV Risk behaviors
time frame: baseline (week 0), treatment-end (week 12), and follow up (week 24)

Eligibility Criteria

Male or female participants from 18 years up to 59 years old.

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.

Additional Information

Official title Mindfulness Based Relapse Prevention for Stimulant Users
Principal investigator Suzette Glasner-Edwards, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of California, Los Angeles.