Trial record 3 of 6 for:    Open Studies | amphetamine (abuse OR dependence)

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by California Pacific Medical Center Research Institute
Sponsor:
Information provided by (Responsible Party):
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01899313
First received: May 30, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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 Intervention
Amphetamine-Related Disorders
Behavioral: CBT- based SMS text messaging intervention
Behavioral: CBT group therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:
  • Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: May 2014
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: May 30, 2013
Last Updated: May 12, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014