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Clinical Trials/NCT01899313
NCT01899313UnknownNot Applicable

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

California Pacific Medical Center Research Institute2 sites in 1 country50 target enrollmentStarted: May 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
2
Primary Endpoint
Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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,

Arms & Interventions

CBT- based SMS text messaging intervention

Experimental

cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention

Intervention: CBT group therapy (Behavioral)

CBT- based SMS text messaging intervention

Experimental

cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention

Intervention: CBT- based SMS text messaging intervention (Behavioral)

Placebo Texts

Placebo Comparator

Placebo texts will be given instead of interventional texts

Intervention: CBT group therapy (Behavioral)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Gantt Galloway, PharmD

Senior Scientist

California Pacific Medical Center Research Institute

Study Sites (2)

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