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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Methamphetamine Dependence

Intervention / Treatment
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* Behavioral: Text messages


Participation Criteria
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Eligibility Criteria
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Main inclusion criterion: English-speaking adults who are currently seeking treatment for methamphetamine addiction

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT-based text messages - Week 1 or 3<br>One week CBT-based text messages followed by a 1-week washout period (Week 2) | Behavioral: Text messages<br>* Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine<br>|
| Placebo Comparator: Placebo text messages - Week 3 or 1<br> | Behavioral: Text messages<br>* Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Methamphetamine, Drug Abuse, Substance Abuse, Amphetamine, Dependence, Addiction, Craving, Cognitive Behavioral Therapy, Text Messaging