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Completed

NCT Number: NCT01577797

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.

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Key information

Conditions

Methamphetamine Dependence Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Impulsive Behavior Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Leaf Treatment Center

Lafayette, California, 94549, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main inclusion criterion:

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

Treatment and study plan

Text Messages

Behavioral

Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine

Primary outcomes

  1. Feasibility of the intervention in methamphetamine users

    Time frame: 22 days

    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).

Secondary outcomes

  1. Acceptability of the intervention in methamphetamine users

    Time frame: 22 days

    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?

Sponsors and collaborators

Lead sponsor

New Leaf Treatment Center

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 16, 2012
Registry last updated
Jul 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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