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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01899313
Recruitment Status : Unknown
Verified May 2014 by Gantt Galloway, PharmD, California Pacific Medical Center Research Institute.
Recruitment status was:  Recruiting
First Posted : July 15, 2013
Last Update Posted : May 14, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Amphetamine-Related Disorders Behavioral: CBT- based SMS text messaging intervention Behavioral: CBT group therapy

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
Study Start Date : May 2014
Estimated Primary Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arms and Interventions

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 Name: Cognitive Behavioral Group Therapy
Placebo Comparator: Placebo Texts
Placebo texts will be given instead of interventional texts
Behavioral: CBT group therapy
Other Name: Cognitive Behavioral Group Therapy


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01899313


Contacts
Contact: Kathleen Garrison 415-600-3126 garrisk@cpmcri.org
Contact: Reshmi Pal 415-600-1652 palrx@cpmcri.org

Locations
United States, California
New Leaf Treatment Center Recruiting
Lafayette, California, United States, 94549
Contact: Kathleen Garrison    415-600-1652    garrisk@cpmcri.org   
Addiction & Pharmacology Research Laboratory Not yet recruiting
San Francisco, California, United States, 94107
Contact: Kathleen Garrison    415-600-1652    garrisk@cpmcri.org   
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
Principal Investigator: Gantt Galloway, PharmD California Pacific Medical Center
More Information

Additional Information:
Responsible Party: Gantt Galloway, PharmD, Senior Scientist, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT01899313     History of Changes
Other Study ID Numbers: 2012.119-2
First Posted: July 15, 2013    Key Record Dates
Last Update Posted: May 14, 2014
Last Verified: May 2014

Keywords provided by Gantt Galloway, PharmD, California Pacific Medical Center Research Institute:
methamphetamine dependence
texting
short message service
addiction
amphetamine
outpatient

Additional relevant MeSH terms:
Amphetamine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Methamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors