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NCT01899313 Clinical Trial

A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence

Amphetamine-Related Disorders Clinical Trial

Official title:
A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01899313
Other study ID # 2012.119-2
Secondary ID
Status Recruiting
Phase N/A
First received May 30, 2013
Last updated May 12, 2014
Start date May 2014

Study information
Verified date May 2014
Source California Pacific Medical Center Research Institute
Contact Kathleen Garrison
Phone 415-600-3126
Email garrisk@cpmcri.org
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This Phase I behavior therapy development study seeks to improve treatment outcomes for methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- English-speaking adults = 18 years who are seeking treatment for MA addiction.

- Own a cellular phone with SMS text messaging capability and have an unlimited text messaging plan.

- Available to attend CBT therapy groups.

- Agreeable to conditions of the study and signed an informed consent form.

Exclusion Criteria:

- Projected to be unavailable > 12 hours/day to read and send text messages.

- Any medical or psychosocial condition that would preclude safe, useful, or consistent participation,

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Behavioral:
• CBT- based SMS text messaging intervention

• CBT group therapy

Locations
Country Name City State
United States New Leaf Treatment Center Lafayette California
United States Addiction & Pharmacology Research Laboratory San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period The primary efficacy measure for this study is the difference in proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period. Urine samples will be analyzed for MA by immunoassay with a cutoff of 1,000 ng/mL. 5 weeks No
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