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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Leaf Treatment Center
ClinicalTrials.gov Identifier:
NCT01577797
First received: April 5, 2012
Last updated: July 8, 2013
Last verified: July 2013

April 5, 2012
July 8, 2013
April 2012
July 2013   (final data collection date for primary outcome measure)
Feasibility of the intervention in methamphetamine users [ Time Frame: 22 days ] [ Designated as safety issue: No ]
Subjects will respond to >50% of text messaging inquiries (about the usefulness of the messages, maximum degree of craving, and whether they have used that day).
Same as current
Complete list of historical versions of study NCT01577797 on ClinicalTrials.gov Archive Site
Acceptability of the intervention in methamphetamine users [ Time Frame: 22 days ] [ Designated as safety issue: No ]
Based on responses to follow-up visit questionnaires, is 4 times per day the "right amount" of text messages for subjects to receive each day? Is a 13-hour period in which subjects would receive messages appropriate? Was the software system selected for this study acceptable? Were the CBT-based text messages overall perceived as useful? Were the placebo text messages overall perceived as useful?
Same as current
Not Provided
Not Provided
 
A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence
A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence

This Phase I, randomized, 22-day crossover study seeks to improve treatment outcomes for methamphetamine-dependent subjects by developing a cognitive behavioral therapy (CBT)- based short message service (SMS) text messaging intervention as an adjunct to CBT group therapy.

Psychosocial therapies for methamphetamine (MA) addiction all have limited effectiveness, and patients treated for MA dependence have a high rate of relapse. Additionally, there are no currently approved medications for MA dependence. Thus, a significant need exists for add-on therapy for treatment of MA addiction. CBT-based text messaging could serve as a real-time intervention when craving and risk of MA use are high and patients are not in the clinic. It could further serve to reinforce CBT group therapy. If found efficacious, fully-automated CBT-based text messaging would be a relatively inexpensive adjunctive therapy that could be readily scaled up for use in a large number of patients. Additionally, this type of text messaging intervention also could be tailored to individual users, which may enhance its efficacy. This Phase I randomized crossover study will evaluate the feasibility and preliminary efficacy of CBT-based text messages in conjunction with CBT group therapy delivered over a 22-day period in MA users in the San Francisco Bay Area.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Methamphetamine Dependence
Behavioral: Text messages
Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine
  • Experimental: CBT-based text messages - Week 1 or 3
    One week CBT-based text messages followed by a 1-week washout period (Week 2)
    Intervention: Behavioral: Text messages
  • Placebo Comparator: Placebo text messages - Week 3 or 1
    Intervention: Behavioral: Text messages
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
July 2013
July 2013   (final data collection date for primary outcome measure)

Main inclusion criterion:

  • English-speaking adults who are currently seeking treatment for methamphetamine addiction
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01577797
2012-1
No
New Leaf Treatment Center
New Leaf Treatment Center
Not Provided
Principal Investigator: S. Alex Stalcup, MD New Leaf Treatment Center
New Leaf Treatment Center
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP