Integrative Meditation (IM) for Cocaine Addiction

NCT01211418 | Completed DMC

• 2 other identifiers: HP-00040827R21DA025149
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Measurement of cocaine urine toxicology from baseline to 3 month follow-up

  3 month follow-up

Secondary Outcomes (25)

• Compare participants' use of drugs and alcohol from baseline to 3 month follow-up

  3 month follow-up

• Compare heart rate variability from baseline to 4 weeks

  4 weeks

• Compare heart rate variability from 4 weeks to 8 weeks

  8 weeks

• Compare heart rate variability from 8 weeks to 12 weeks

  12 weeks

• Compare heart rate variability from 12 weeks to 3 month follow-up

  3 month follow-up

Study Arms (2)

Integrative Meditation

EXPERIMENTAL

Behavioral: Integrative Meditation

Nondirective Therapy

ACTIVE COMPARATOR

Behavioral: Supportive Counseling

Interventions

Integrative Meditation BEHAVIORAL

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.

Integrative Meditation

Supportive Counseling BEHAVIORAL

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.

Nondirective Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• meets DSM-IV criteria for cocaine dependence or abuse and seeks addiction treatment
• age 18 or older
• used cocaine in the past 3 weeks, and cocaine is one of the major abused substances if using multiple drugs (urine cocaine positive at least once in the past 3 urine tests)
• is willing to adhere to the study protocol (e.g. provide urine samples, attend all visits and follow-ups in the next 6 months).

You may not qualify if:

• poses a current suicidal risk, including active suicidal ideation, recent suicidal behavior or suicide attempt in the past 30 days
• has a history of schizophrenia or other psychotic disorder
• unable to read or understand questions in English
• currently participates in other clinical study on addiction

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Alcohol and Drug Abuse Program (ADAP)

Baltimore, Maryland, 21201, United States

Location

Outpatient Addiction Treatment Service (OATS)

Baltimore, Maryland, 21201, United States

Location

University of Maryland Methadone Treatment Program

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Kevin Chen, PhD

  University of Maryland, Baltimore: Center for Integrative Medicine

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Supervisor

Study Record Dates

• First Submitted: July 28, 2010
• First Posted: September 29, 2010
• Study Start: March 1, 2009
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: March 14, 2022

Record last verified: 2022-02

Locations

US (3)