NCT01577797

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

April 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 16, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 10, 2013

Status Verified

July 1, 2013

Enrollment Period

1.2 years

First QC Date

April 5, 2012

Last Update Submit

July 8, 2013

Conditions

Keywords

MethamphetamineDrug AbuseSubstance AbuseAmphetamineDependenceAddictionCravingCognitive Behavioral TherapyText Messaging

Outcome Measures

Primary Outcomes (1)

  • Feasibility of the intervention in methamphetamine users

    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).

    22 days

Secondary Outcomes (1)

  • Acceptability of the intervention in methamphetamine users

    22 days

Study Arms (2)

CBT-based text messages - Week 1 or 3

EXPERIMENTAL

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

Behavioral: Text messages

Placebo text messages - Week 3 or 1

PLACEBO COMPARATOR
Behavioral: Text messages

Interventions

Text messagesBEHAVIORAL

Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine

CBT-based text messages - Week 1 or 3Placebo text messages - Week 3 or 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Main inclusion criterion: * English-speaking adults who are currently seeking treatment for methamphetamine addiction

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

New Leaf Treatment Center

Lafayette, California, 94549, United States

Location

Related Links

MeSH Terms

Conditions

Substance-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • S. Alex Stalcup, MD

    New Leaf Treatment Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2012

First Posted

April 16, 2012

Study Start

April 1, 2012

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

July 10, 2013

Record last verified: 2013-07

Locations