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

NCT ID: NCT01577797

Last Updated: 2013-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-07-31

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.

Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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CBT-based text messages - Week 1 or 3

One week CBT-based text messages followed by a 1-week washout period (Week 2)

Group Type EXPERIMENTAL

Text messages

Intervention Type 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

Placebo text messages - Week 3 or 1

Group Type PLACEBO_COMPARATOR

Text messages

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* English-speaking adults who are currently seeking treatment for methamphetamine addiction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New Leaf Treatment Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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S. Alex Stalcup, MD

Role: PRINCIPAL_INVESTIGATOR

New Leaf Treatment Center

Locations

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New Leaf Treatment Center

Lafayette, California, United States

Site Status

Countries

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United States

Other Identifiers

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2012-1

Identifier Type: -

Identifier Source: org_study_id

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