A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
1 other identifier
interventional
50
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2013
CompletedFirst Posted
Study publicly available on registry
July 15, 2013
CompletedStudy Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedMay 14, 2014
May 1, 2014
8 months
May 30, 2013
May 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
CBT- based SMS text messaging intervention
EXPERIMENTALcognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention
Placebo Texts
PLACEBO COMPARATORPlacebo texts will be given instead of interventional texts
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
New Leaf Treatment Center
Lafayette, California, 94549, United States
Addiction & Pharmacology Research Laboratory
San Francisco, California, 94107, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gantt Galloway, PharmD
California Pacific Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
May 30, 2013
First Posted
July 15, 2013
Study Start
May 1, 2014
Primary Completion
January 1, 2015
Last Updated
May 14, 2014
Record last verified: 2014-05