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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New Leaf Treatment Center
ClinicalTrials.gov Identifier:
NCT01577797
First received: April 5, 2012
Last updated: July 8, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by New Leaf Treatment Center:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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?


Enrollment: 25
Study Start Date: April 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (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
Criteria

Main inclusion criterion:

  • English-speaking adults who are currently seeking treatment for methamphetamine addiction
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577797

Locations
United States, California
New Leaf Treatment Center
Lafayette, California, United States, 94549
Sponsors and Collaborators
New Leaf Treatment Center
Investigators
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: July 8, 2013
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
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014