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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00744068
Other study ID # R01DA018208-01A1
Secondary ID R01DA018208
Status Completed
Phase N/A
First received August 28, 2008
Last updated November 23, 2016
Start date April 2006
Est. completion date September 2011

Study information

Verified date November 2016
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The overall objective of this research is to develop and refine empirically supported continuing care interventions that promote healthy behavior and sustained abstinence from illicit drug use.


Description:

For treatment interventions to provide the desired result of long term abstinence, it is important to develop strategies to enhance the effectiveness of continued care approaches. We plan to conduct a prospective, randomized comparison of four models of counselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program. Some 500 participants completing a 4-month Matrix Outpatient Model of stimulant abuse treatment will be randomly assigned to one of four counseling groups (n=100 per group): (1) unstructured/non-directive, (2) structured/non-directive, (3) unstructured/directive, or (4) structured/directive telephone counseling, or (5) a control group consisting of standard referral to Matrix aftercare, for a total sample size of 500. The two structured conditions will be based on the behavioral "prompts" identified by Farabee et al. (2002)* as being associated with drug avoidance. In the non-directive conditions, subjects will be allowed to state their own goals and how they intend to achieve them. In the directive conditions, the counselor will provide specific recommendations to help the subject adopt as many of the drug-avoidance activities as possible. Outcomes will be tracked for 12 months following completion of primary treatment (a total of 16 months after treatment admission) and will include measurement of participation in drug-avoidance activities (including aftercare participation) as well as self-reported and objective measures of substance use and related behavior change.

*Farabee, D., Rawson, R.A., & McCann, M. (2002). Adoption of drug avoidance activities among patients in contingency management and cognitive-behavioral treatments. Journal of Substance Abuse Treatment, 23, 343-350.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date September 2011
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Males or females, 18-65 years of age.

- Meet DSM-IV criteria (at the time of treatment admission) for cocaine or methamphetamine abuse/dependence.

- Have completed the primary phase of treatment at a Matrix outpatient clinic.

- Have telephone access throughout the study procedures.

- Be able to understand and complete rating scales and to follow instructions.

- Be willing to sign an informed consent form.

Exclusion Criteria:

- Have participated in a treatment-related study conducted by the PI and colleagues during the previous 3 years and/or is currently enrolled in a treatment-related study.

- Have any medical, legal, housing or transportation problem which would preclude either safe or consistent participation.

- Have dropped out of the primary phase of treatment prior to completion.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Continuing Care Telephone Support
Counselor-provided telephone support as strategies to promote patient aftercare attendance and sustained abstinence from stimulant use. To this end, we will develop and compare the efficacy of four low-cost telephone support protocols for patients who have completed the intensive phase of a structured, outpatient stimulant abuse treatment program.

Locations

Country Name City State
United States Twin Town Treatment Center Los Alamitos California
United States Matrix Institute on Addictions Los Angeles California
United States UCLA Integrated Substance Abuse Programs Los Angeles California
United States Matrix Institute on Addictions Rancho Cucamonga California
United States Twin Town Treatment Center West Hollywood California
United States Matrix Institute on Addicitions Woodland Hills California

Sponsors (2)

Lead Sponsor Collaborator
University of California, Los Angeles National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (48)

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* Note: There are 48 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Urinalyses At 3 months and 12 months No
Primary Breathalyzer tests At 3 months and 12 months No
Primary Self-report of drug or alcohol use At 3 months and 12 months No
Primary Amount of Treatment Activities At 3 months and 12 months No
Primary Length of Treatment Episode At 3 months and 12 months No
Secondary Addiction Severity Index (ASI) At 3 months and 12 months No
Secondary HIV Risk-taking Behavior Scale At 3 months and 12 months No
Secondary Concurrent Psychosocial Treatments At 3 months and 12 months No
Secondary Drug Avoidance Activities (DAA) Survey At 3 months and 12 months No
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