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

Primary Purpose

Amphetamine-Related Disorders

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT- based SMS text messaging intervention
CBT group therapy
Sponsored by
California Pacific Medical Center Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amphetamine-Related Disorders focused on measuring methamphetamine dependence, texting, short message service, addiction, amphetamine, outpatient

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • English-speaking adults ≥ 18 years who are seeking treatment for MA addiction.
  • Own a cellular phone with SMS text messaging capability and have an unlimited text messaging plan.
  • Available to attend CBT therapy groups.
  • Agreeable to conditions of the study and signed an informed consent form.

Exclusion Criteria:

  • Projected to be unavailable > 12 hours/day to read and send text messages.
  • Any medical or psychosocial condition that would preclude safe, useful, or consistent participation,

Sites / Locations

  • New Leaf Treatment CenterRecruiting
  • Addiction & Pharmacology Research Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBT- based SMS text messaging intervention

Placebo Texts

Arm Description

cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention

Placebo texts will be given instead of interventional texts

Outcomes

Primary Outcome Measures

Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period
The primary efficacy measure for this study is the difference in proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period. Urine samples will be analyzed for MA by immunoassay with a cutoff of 1,000 ng/mL.

Secondary Outcome Measures

Full Information

First Posted
May 30, 2013
Last Updated
May 12, 2014
Sponsor
California Pacific Medical Center Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01899313
Brief Title
A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
Official Title
A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
January 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
California Pacific Medical Center Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This Phase I behavior therapy development study seeks to improve treatment outcomes for methamphetamine (MA)-dependent subjects by developing a novel cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amphetamine-Related Disorders
Keywords
methamphetamine dependence, texting, short message service, addiction, amphetamine, outpatient

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CBT- based SMS text messaging intervention
Arm Type
Experimental
Arm Description
cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention
Arm Title
Placebo Texts
Arm Type
Placebo Comparator
Arm Description
Placebo texts will be given instead of interventional texts
Intervention Type
Behavioral
Intervention Name(s)
CBT- based SMS text messaging intervention
Intervention Type
Behavioral
Intervention Name(s)
CBT group therapy
Other Intervention Name(s)
Cognitive Behavioral Group Therapy
Primary Outcome Measure Information:
Title
Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period
Description
The primary efficacy measure for this study is the difference in proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period. Urine samples will be analyzed for MA by immunoassay with a cutoff of 1,000 ng/mL.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English-speaking adults ≥ 18 years who are seeking treatment for MA addiction. Own a cellular phone with SMS text messaging capability and have an unlimited text messaging plan. Available to attend CBT therapy groups. Agreeable to conditions of the study and signed an informed consent form. Exclusion Criteria: Projected to be unavailable > 12 hours/day to read and send text messages. Any medical or psychosocial condition that would preclude safe, useful, or consistent participation,
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Garrison
Phone
415-600-3126
Email
garrisk@cpmcri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Reshmi Pal
Phone
415-600-1652
Email
palrx@cpmcri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gantt Galloway, PharmD
Organizational Affiliation
California Pacific Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Leaf Treatment Center
City
Lafayette
State/Province
California
ZIP/Postal Code
94549
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Garrison
Phone
415-600-1652
Email
garrisk@cpmcri.org
Facility Name
Addiction & Pharmacology Research Laboratory
City
San Francisco
State/Province
California
ZIP/Postal Code
94107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathleen Garrison
Phone
415-600-1652
Email
garrisk@cpmcri.org

12. IPD Sharing Statement

Learn more about this trial

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

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