A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Methamphetamine Dependence |
Behavioral: Text messages |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | A Cognitive Behavioral Therapy-Based Text Messaging Intervention for Methamphetamine Dependence |
- Feasibility of the intervention in methamphetamine users [ Time Frame: 22 days ] [ Designated as safety issue: No ]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).
- Acceptability of the intervention in methamphetamine users [ Time Frame: 22 days ] [ Designated as safety issue: No ]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?
| Estimated Enrollment: | 25 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | November 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CBT-based text messages - Week 1 or 3
One week CBT-based text messages followed by a 1-week washout period (Week 2)
|
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
|
| Placebo Comparator: Placebo text messages - Week 3 or 1 |
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Main inclusion criterion:
- English-speaking adults who are currently seeking treatment for methamphetamine addiction
Contacts and Locations| Contact: Vicky Keoleian | 925 284 5200 | |
| Contact: Elke Jacobsen | 925 284 5200 |
| United States, California | |
| New Leaf Treatment Center | Recruiting |
| Lafayette, California, United States, 94549 | |
| Principal Investigator: | S. Alex Stalcup, MD | New Leaf Treatment Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | New Leaf Treatment Center |
| ClinicalTrials.gov Identifier: | NCT01577797 History of Changes |
| Other Study ID Numbers: | 2012-1 |
| Study First Received: | April 5, 2012 |
| Last Updated: | April 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New Leaf Treatment Center:
|
Methamphetamine Drug Abuse Substance Abuse Amphetamine Dependence |
Addiction Craving Cognitive Behavioral Therapy Text Messaging |
Additional relevant MeSH terms:
|
Methamphetamine Amphetamine Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013