Integrative Meditation (IM) for Cocaine Addiction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University of Maryland.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT01211418
First received: July 28, 2010
Last updated: September 28, 2010
Last verified: September 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Maryland:

Primary Outcome Measures:
  • Measurement of cocaine urine toxicology from baseline to 3 month follow-up [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01211418

Contacts
Contact: Kevin Chen, PhD 410-706-6188 kchen@compmed.umm.edu
Contact: Gabrielle Gill, MA 410-706-6154 ggill@compmed.umm.edu

Locations
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   
Sponsors and Collaborators
University of Maryland
Investigators
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
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014