Integrative Meditation (IM) for Cocaine Addiction
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cocaine Addiction |
Behavioral: Integrative Meditation Behavioral: Supportive Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Cocaine Addiction With Integrative Meditation |
- Measurement of cocaine urine toxicology from baseline to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
- Compare participants' use of drugs and alcohol from baseline to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
- Compare heart rate variability from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Compare heart rate variability from 4 weeks to 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Compare heart rate variability from 8 weeks to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Compare heart rate variability from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
- Change in Addiction Severity Index (ASI lite) composite scores from baseline to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
- Track participant's length of time in a drug treatment program from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Track participant's length of time in a drug treatment program from 4 weeks to 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Track participant's length of time in a drug treatment program from 8 weeks to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Compare participants' weekly cocaine cravings from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Compare participants' cocaine cravings from 4 weeks to 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Compare participants' cocaine cravings from 8 weeks to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Compare participants' cocaine cravings from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
- Change in Beck Depression Inventory-II (BDI-II) composite scores from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in Beck Depression Inventory-II (BDI-II) composite scores from 4 weeks to 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in Beck Depression Inventory-II (BDI-II) composite scores from 8 weeks to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Beck Depression Inventory-II (BDI-II) composite scores from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
- Change in participants' weekly Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 4 weeks to 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 8 weeks to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
- Change in Self-efficacy and Self-esteem (SES) composite scores from baseline to 4 weeks [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
- Change in Self-efficacy and Self-esteem (SES) composite scores from 4 weeks to 8 weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in Self-efficacy and Self-esteem (SES) composite scores from 8 weeks to 12 weeks [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Self-efficacy and Self-esteem (SES) composite scores from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 70 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Integrative Meditation |
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. |
| Active Comparator: Nondirective Therapy |
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. |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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
Contacts and Locations| Contact: Kevin Chen, PhD | 410-706-6188 | kchen@compmed.umm.edu |
| Contact: Gabrielle Gill, MA | 410-706-6154 | ggill@compmed.umm.edu |
| United States, Maryland | |
| Outpatient Addiction Treatment Service (OATS) | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Receptionist 410-328-6600 | |
| Alcohol and Drug Abuse Program (ADAP) | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Amy Jackson 410-328-0126 | |
| University of Maryland Methadone Treatment Program | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Jewell Benford 410-837-3313 jbenford@psych.umaryland.edu | |
| Study Director: | Kevin Chen, PhD | University of Maryland, Baltimore: Center for Integrative Medicine |
More Information
No publications provided
| Responsible Party: | Dr. Kevin Chen, University of Maryland School of Medicine |
| ClinicalTrials.gov Identifier: | NCT01211418 History of Changes |
| Other Study ID Numbers: | HP-00040827, R21DA025149 |
| Study First Received: | July 28, 2010 |
| Last Updated: | September 28, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Behavior, Addictive Cocaine-Related Disorders Compulsive Behavior |
Impulsive Behavior Substance-Related Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 21, 2013