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

May 12, 2014 updated by: Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Lafayette, California, United States, 94549
        • Recruiting
        • New Leaf Treatment Center
        • Contact:
      • San Francisco, California, United States, 94107
        • Not yet recruiting
        • Addiction & Pharmacology Research Laboratory
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CBT- based SMS text messaging intervention
cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention
Behavioral: CBT- based SMS text messaging intervention
Behavioral: CBT group therapy
Other Names:
  • Cognitive Behavioral Group Therapy
Placebo Comparator: Placebo Texts
Placebo texts will be given instead of interventional texts
Behavioral: CBT group therapy
Other Names:
  • Cognitive Behavioral Group Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period
Time Frame: 5 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

California Pacific Medical Center Research Institute

Investigators

  • Principal Investigator: Gantt Galloway, PharmD, California Pacific Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

July 11, 2013

First Posted (Estimate)

July 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 12, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012.119-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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