Clinical Trial: Integrative Meditation (IM) for Cocaine Addiction

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Treatment of Cocaine Addiction With Integrative Meditation

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.


Detailed Summary:

Randomization Procedure:

Subjects who meet DSM-IV cocaine dependence or abuse and other inclusion criteria will be randomly assigned to an IM or NT group, using an adaptive urn randomization procedure, which adjusts for gender, referral source (self-referred or count-mandated), psychiatric medication (yes/no), and type of cocaine addiction (polydrug vs. cocaine only). Simple randomization may not be adequate to assure a balance between the groups of known predictive indicators. While the primary basis of assignment remains randomization, urn randomization biases assignment towards balance between groups based on variables known to be related to treatment outcome when sample sizes are intermediate. Randomization reduces the possibility that one group will be assigned a disproportionate number of the few patients in certain subgroup.

Overview of the Treatment Procedure Twelve treatment sessions over 12 weeks will occur in the outpatient facility once a week, about 30 minutes each session. Treatment outcomes will be assessed at weeks 4, 8, 12, and 24 (3 months after treatment). The follow-up assessments can occur either at the outpatient facility, or at our offices in University of Maryland (Kernan Hospital). We will make the follow-up sessions at both sites equivalent to each other, and provide financial compensation for individuals who travel to our campus. For those who do not want to come to the University, we will ensure that the follow-up sessions at the treatment facility will be held in a private room separate from the location of staff and patients to ensure privacy. Subjects are clearly assured that no one at the treatment facility will have access to their treatment outcome data.

We considered having the same therapists deliver both treatments to limit therapist-spe
Sponsor: University of Maryland

Current Primary Outcome: Measurement of cocaine urine toxicology from baseline to 3 month follow-up [ Time Frame: 3 month follow-up ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Compare participants' use of drugs and alcohol from baseline to 3 month follow-up [ Time Frame: 3 month follow-up ]
  • Compare heart rate variability from baseline to 4 weeks [ Time Frame: 4 weeks ]
  • Compare heart rate variability from 4 weeks to 8 weeks [ Time Frame: 8 weeks ]
  • Compare heart rate variability from 8 weeks to 12 weeks [ Time Frame: 12 weeks ]
  • Compare heart rate variability from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ]
  • Change in Addiction Severity Index (ASI lite) composite scores from baseline to 3 month follow-up [ Time Frame: 3 month follow-up ]
  • Track participant's length of time in a drug treatment program from baseline to 4 weeks [ Time Frame: 4 weeks ]
  • Track participant's length of time in a drug treatment program from 4 weeks to 8 weeks [ Time Frame: 8 weeks ]
  • Track participant's length of time in a drug treatment program from 8 weeks to 12 weeks [ Time Frame: 12 weeks ]
  • Compare participants' weekly cocaine cravings from baseline to 4 weeks [ Time Frame: 4 weeks ]
  • Compare participants' cocaine cravings from 4 weeks to 8 weeks [ Time Frame: 8 weeks ]
  • Compare participants' cocaine cravings from 8 weeks to 12 weeks [ Time Frame: 12 weeks ]
  • Compare participants' cocaine cravings from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ]
  • Change in Beck Depression Inventory-II (BDI-II) composite scores from baseline to 4 weeks [ Time Frame: 4 weeks ]
  • Change in Beck Depression Inventory-II (BDI-II) composite scores from 4 weeks to 8 weeks [ Time Frame: 8 weeks ]
  • Change in Beck Depression Inventory-II (BDI-II) composite scores from 8 weeks to 12 weeks [ Time Frame: 12 weeks ]
  • Change in Beck Depression Inventory-II (BDI-II) composite scores from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ]
  • Change in participants' weekly Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from baseline to 4 weeks [ Time Frame: 4 weeks ]
  • Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 4 weeks to 8 weeks [ Time Frame: 8 weeks ]
  • Change in Spielberger State-Trait Anxiety Inventory state version (STAI) composite scores from 8 weeks to 12 weeks [ Time Frame: 12 weeks ]
  • 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 ]
  • Change in Self-efficacy and Self-esteem (SES) composite scores from baseline to 4 weeks [ Time Frame: 4 weeks ]
  • Change in Self-efficacy and Self-esteem (SES) composite scores from 4 weeks to 8 weeks [ Time Frame: 8 weeks ]
  • Change in Self-efficacy and Self-esteem (SES) composite scores from 8 weeks to 12 weeks [ Time Frame: 12 weeks ]
  • Change in Self-efficacy and Self-esteem (SES) composite scores from 12 weeks to 3 month follow-up [ Time Frame: 3 month follow-up ]


Original Secondary Outcome: Same as current

Information By: University of Maryland

Dates:
Date Received: July 28, 2010
Date Started: March 2009
Date Completion: March 2011
Last Updated: September 28, 2010
Last Verified: September 2010