Integrative Meditation (IM) for Cocaine Addiction

NCT01211418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2022-03-14

No results posted yet for this study

Summary

Cocaine addiction continues to be a major problem in the U.S. with no FDA-approved pharmaceutical therapy. Finding effective treatment for cocaine addiction has long been a challenge to scientists and clinicians. Psychosocial interventions known as behavior therapies are the cornerstone of cocaine addiction treatment. However, there is an urgent need to further improve treatment outcomes, especially during early recovery and the protracted withdrawal phase of the treatment since many patients drop out or relapse during this phase. Our clinical experience and studies suggest that integrative Meditation (IM) helps reduce cravings and withdrawal symptoms and increases treatment retention. The benefit of IM is well supported by tension-reduction theory and attention-networks framework in addiction treatment. The proposed study will implement a therapy development study to add IM as a self-care component to the current outpatient treatment of cocaine addiction to improve treatment outcomes.

The specific aims of the proposed study include: 1) to conduct a 12-week controlled trial with outpatient cocaine users to assess feasibility of recruiting and retaining cocaine addicts and to determine effect size of IM-augmented treatment in comparison with Nondirective Therapy (NT) control, with both groups receiving standard outpatient treatment as usual (TAU), thereby facilitating future larger scale therapy development study; and 2) to examine the changes in attention networks and negative mood as possible mediators of treatment outcomes between the two groups.

Conditions

  • Cocaine Addiction

Interventions

BEHAVIORAL

Integrative Meditation

Stage 1: Treatment Engagement and Detoxification. Use 6 breaths/minute as near resonant-frequency. Stage 2: Recovery and transition by reducing craving and irritability. Wk 3: introduce 16-mins IM. Wk 4: RFB \& IM as a coping tool. Wk 5: add guided imagery into IM. Wk 6: review and catch-up if miss any prior sections. Stage 3: Revitalization and Relapse Prevention. Wk 7: customize guided imagery. Wk 8: introduce full version of IM. Wk 9: techniques of handling random thoughts during meditation and learn to separate thoughts from action. Wk 10: how to use IM techniques to handle different relapse triggers. Wk 11: different ways to integrate IM technique into daily life. Wk 12: review, feedback, and provide local sources for more meditation practice and study.

BEHAVIORAL

Supportive Counseling

NT is a procedure in which the therapist refrains from directing the client, but instead reflects back to the client what the latter has said. NT is chosen for this study to control for non-specific effects that show to contribute to outcome such as therapeutic alliance and therapist competency. The protocol for the individualized NT will mirror the layout of IM therapy -12 weekly meetings, 30 minutes each. Subjects in NT group will be instructed to do Diaphragmatic Breathing (DB) exercise and will be given assigned homework (writing journal) and track progress. DB is incorporated into the NT as treatment providing non-specific effects associated with attention and homework completion.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH
  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Kevin Chen, PhD · University of Maryland, Baltimore: Center for Integrative Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01211418 on ClinicalTrials.gov