Trial record 10 of 33 for:
Open Studies | amphetamine (abuse OR dependence)
A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
This study is currently recruiting participants.
Verified August 2012 by California Pacific Medical Center Research Institute
Sponsor:
California Pacific Medical Center Research Institute
Information provided by (Responsible Party):
Gantt Galloway, PharmD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT01354470
First received: May 12, 2011
Last updated: August 10, 2012
Last verified: August 2012
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Purpose
The proposed study will establish the safety and efficacy of modafinil in the treatment of methamphetamine dependence, as well as assess the affects of modafinil on cognitive function in methamphetamine users and on methamphetamine withdrawal symptoms. In this outpatient trial, methamphetamine- dependent, treatment-seeking subjects will receive modafinil or placebo daily for four weeks, along with weekly Motivational Enhancement Therapy sessions. This study will be conducted at the Addiction & Pharmacology Laboratory in San Francisco, CA, and at the New Leaf Treatment Center in Lafayette, CA, and is expected to last one year.
| Condition | Intervention | Phase |
|---|---|---|
|
Methamphetamine Dependence |
Drug: Modafinil |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence |
Resource links provided by NLM:
MedlinePlus related topics:
Methamphetamine
Drug Information available for:
Methamphetamine hydrochloride
Amphetamine
Methamphetamine
Modafinil
Armodafinil
U.S. FDA Resources
Further study details as provided by California Pacific Medical Center Research Institute:
Primary Outcome Measures:
- Urine Samples Negative for Methamphetamine [ Time Frame: Twice weekly for 4 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 72 |
| Study Start Date: | October 2011 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Modafinil |
Drug: Modafinil
600 mg Modafinil capsule
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age between 18 and 50 years
- Patient is agreeable to conditions of study and signs consent form
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354470
Contacts
| Contact: Kathleen Garrison | 415-641-3370 | garrisk@cpmcri.org |
Locations
| United States, California | |
| New Leaf Treatment Center | Not yet recruiting |
| Lafayette, California, United States, 94549 | |
| Contact: Kathleen Garrison 415-641-3370 | |
| CPMC Research Institute, St.Luke's Hospital | Recruiting |
| San Francisco, California, United States, 94110 | |
| Contact: Kathleen Garrison 415-641-3370 | |
Sponsors and Collaborators
California Pacific Medical Center Research Institute
Investigators
| Principal Investigator: | Gantt Galloway, PharmD | California Pacific Medical Center |
More Information
No publications provided
| Responsible Party: | Gantt Galloway, PharmD, Scientist, California Pacific Medical Center Research Institute |
| ClinicalTrials.gov Identifier: | NCT01354470 History of Changes |
| Other Study ID Numbers: | CPMC-APRL-8B |
| Study First Received: | May 12, 2011 |
| Last Updated: | August 10, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by California Pacific Medical Center Research Institute:
|
Meth Methamphetamine Addiction Methamphetamine Treatment Modafinil |
Additional relevant MeSH terms:
|
Methamphetamine Amphetamine Modafinil Sympathomimetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Dopamine Agents Neurotransmitter Agents |
Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Adrenergic Agents Adrenergic Uptake Inhibitors Neurotransmitter Uptake Inhibitors Dopamine Uptake Inhibitors Neuroprotective Agents Protective Agents |
ClinicalTrials.gov processed this record on May 19, 2013