Amphetamine-Related DisordersNCT01899313
A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
A study testing CBT- based SMS text messaging intervention and CBT group therapy in people with Amphetamine-Related Disorders, run by California Pacific Medical Center Research Institute at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amphetamine-Related Disorders
- What is being tested?
- CBT- based SMS text messaging intervention and CBT group therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2014to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
New Leaf Treatment Center
Lafayette, California, 94549
Kathleen Garrison, 415-600-1652, garrisk@cpmcri.org
- Not yet recruiting
Addiction & Pharmacology Research Laboratory
San Francisco, California, 94107
Kathleen Garrison, 415-600-1652, garrisk@cpmcri.org
About this study
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.
- Conditions
- Amphetamine-Related Disorders
- Being tested
- CBT- based SMS text messaging intervention, CBT group therapy
- Keywords
- methamphetamine dependence, texting, short message service, addiction, amphetamine, outpatient
- Medical subject headings
- Amphetamine-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT- based SMS text messaging interventionBehavioural
CBT group therapyBehavioural
Also called Cognitive Behavioral Group Therapy
| Study group | Role | What they receive |
|---|---|---|
| CBT- based SMS text messaging intervention | Experimental | cognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention Receives: Behavioral: CBT- based SMS text messaging intervention; Behavioral: CBT group therapy |
| Placebo Texts | Placebo comparator | Placebo texts will be given instead of interventional texts Receives: Behavioral: CBT group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2013 (estimated)
- Study startMay 2014
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amphetamine-Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- California Pacific Medical Center Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
- Investigators
- Gantt Galloway, PharmD, Principal investigator, California Pacific Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01899313
- Sponsor's protocol ID
- 2012.119-2
- Status last verified
- May 2014
- First submitted
- 30 May 2013
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cognitive Behavioral Therapy-Based Text Message Intervention for Methamphetamine Dependence
- ClinicalTrials.gov ID
- NCT01899313
- Acronym / sponsor ID
- 2012.119-2
- Conditions
- Amphetamine-Related Disorders
- Keywords
- methamphetamine dependence, texting, short message service, addiction, amphetamine, outpatient
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- California Pacific Medical Center Research InstituteUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jan 2015 (estimated)
- First posted
- 15 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT- based SMS text messaging intervention | Experimental | Behavioral: CBT- based SMS text messaging intervention, Behavioral: CBT group therapycognitive behavioral therapy- (CBT-) based short message service (SMS) text messaging intervention |
| Placebo Texts | Placebo comparator | Behavioral: CBT group therapyPlacebo texts will be given instead of interventional texts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBT- based SMS text messaging intervention | Behavioural | CBT- based SMS text messaging intervention |
| CBT group therapyAlso: Cognitive Behavioral Group Therapy | Behavioural | CBT- based SMS text messaging intervention, Placebo Texts |
Primary outcome
Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period
Time frame: 5 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gantt Galloway, PharmD principal investigator
California Pacific Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT- based SMS text messaging intervention and CBT group therapy in people with Amphetamine-Related Disorders, run by California Pacific Medical Center Research Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Garrison (415-600-3126, garrisk@cpmcri.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of MA-negative urine samples between the 2-week CBT text period and the 2-week control period (time frame: 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.