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Clinical Trials/NCT01577797
NCT01577797CompletedPhase 1

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

New Leaf Treatment Center1 site in 1 country25 target enrollmentStarted: April 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
25
Locations
1
Primary Endpoint
Feasibility of the intervention in methamphetamine users

Study Overview

Brief 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.

Detailed 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Single (Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

CBT-based text messages - Week 1 or 3

Experimental

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

Intervention: Text messages (Behavioral)

Placebo text messages - Week 3 or 1

Placebo Comparator

Intervention: Text messages (Behavioral)

Outcomes

Primary Outcomes

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

  • Acceptability of the intervention in methamphetamine users(22 days)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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