NCT01094223

Brief Summary

The broad, long-term objective of the current research is to improve treatment for stimulant use disorders by augmenting traditional relapse prevention therapy with innovative meditation-based strategies to promote affect regulation skills. Based on Mindfulness-Based Cognitive Therapy for depression (Segal, Teasdale, \& Williams, 2002), Marlatt and colleagues recently developed a manualized intervention for the treatment of substance using populations: Mindfulness Based Relapse Prevention (MBRP). The specific aims of this research are 1) To conduct a pilot randomized clinical trial to assess the feasibility of recruiting and retaining individuals for a large scale study and to determine the effect size of MBRP relative to a health education (ED) control group in stimulant users receiving contingency management (CM).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

April 29, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

March 25, 2010

Last Update Submit

April 22, 2022

Conditions

Keywords

StimulantAddictionMindfulnessTreatment

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    The Beck Depression Inventory (BDI), a well validated self-report measure (Beck, 1967) will be administered at baseline, weekly during treatment, and at follow-up. Both the absolute total scores and change scores will be used for analyses.

    baseline (week 0), weekly during treatment (weeks 1-12), and at follow-up (week 24)

Secondary Outcomes (1)

  • HIV Risk behaviors

    baseline (week 0), treatment-end (week 12), and follow up (week 24)

Study Arms (2)

Mindfulness

EXPERIMENTAL

Mindfulness Based Relapse Prevention (MBRP). Meditation based therapy group incorporating relapse prevention skills training.

Behavioral: Mindfulness Based Relapse Prevention

Health Education

ACTIVE COMPARATOR

Health education, psychoeducation group focused on various topics pertaining to physical health

Behavioral: Health Education

Interventions

Meditation based therapy group incorporating relapse prevention skills training

Mindfulness

Psychoeducation group focused on various topics pertaining to physical health

Health Education

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18 to 59
  • DSM-IV diagnosis of Stimulant Dependence
  • Able to provide informed consent
  • Willing and able to participate in study procedures

You may not qualify if:

  • Presence of life threatening or unstable medical illness, such as acute pulmonary, cardiovascular, or musculoskeletal disease, that would require treatment or make study participation difficult
  • Lack of proficiency in English
  • Currently homeless (unless residing in a recovery home for which contact information can be provided)
  • Dependence on an illicit substance for which medical detoxification is imminently needed.
  • Presence of clinically significant psychiatric symptoms as assessed by MINI, such as psychosis or acute mania, that would require ongoing treatment or make study compliance difficult.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA

Los Angeles, California, 90025, United States

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Suzette Glasner, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

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
Principal Investigator

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2012

Study Completion

December 1, 2012

Last Updated

April 29, 2022

Record last verified: 2022-04

Locations