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

Methamphetamine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577797
• Other study ID #: 2012-1
• Status: Completed
• Phase: Phase 1
• First received: April 5, 2012
• Last updated: July 8, 2013
• Start date: April 2012
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: New Leaf Treatment Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Main inclusion criterion:

• English-speaking adults who are currently seeking treatment for methamphetamine addiction

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Methamphetamine Dependence

Intervention

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

Locations

Country	Name	City	State
United States	New Leaf Treatment Center	Lafayette	California

Sponsors (1)

Lead Sponsor	Collaborator
New Leaf Treatment Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of the intervention in methamphetamine users	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).	22 days	No
Secondary	Acceptability of the intervention in methamphetamine users	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?	22 days	No

External Links

•   New Leaf Treatment Center website