NCT01899313

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 15, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Last Updated

May 14, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

May 30, 2013

Last Update Submit

May 12, 2014

Conditions

Keywords

methamphetamine dependencetextingshort message serviceaddictionamphetamineoutpatient

Outcome Measures

Primary Outcomes (1)

  • 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.

    5 weeks

Study Arms (2)

CBT- based SMS text messaging intervention

EXPERIMENTAL

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

Behavioral: CBT- based SMS text messaging interventionBehavioral: CBT group therapy

Placebo Texts

PLACEBO COMPARATOR

Placebo texts will be given instead of interventional texts

Behavioral: CBT group therapy

Interventions

CBT- based SMS text messaging intervention
Also known as: Cognitive Behavioral Group Therapy
CBT- based SMS text messaging interventionPlacebo Texts

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

New Leaf Treatment Center

Lafayette, California, 94549, United States

RECRUITING

Addiction & Pharmacology Research Laboratory

San Francisco, California, 94107, United States

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Amphetamine-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Gantt Galloway, PharmD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Garrison

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

May 30, 2013

First Posted

July 15, 2013

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Last Updated

May 14, 2014

Record last verified: 2014-05

Locations