Rivastigmine For Methamphetamine Dependent Individuals
Double-Blind Randomized Placebo Controlled Trial of Rivastigmine (Excelon) as a Potential Medication for Methamphetamine Abuse
3 other identifiers
interventional
18
1 country
1
Brief Summary
Methamphetamine abuse has been steadily increasing over the past decade. Rivastigmine is a medication that may be helpful in treating methamphetamine dependence. The purpose of this study is to evaluate the effectiveness of rivastigmine in treating methamphetamine dependent individuals.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2006
1 active site
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
September 8, 2005
CompletedFirst Posted
Study publicly available on registry
September 12, 2005
CompletedStudy Start
First participant enrolled
May 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedJanuary 12, 2017
September 1, 2009
10 months
September 8, 2005
January 11, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Methamphetamine abstinence
Interventions
Eligibility Criteria
You may qualify if:
- Speaks English
- Not seeking treatment for methamphetamine dependence at study entry
- Meets DSM-IV criteria for methamphetamine abuse or dependence
- Smokes or intravenously uses methamphetamine
- Resting pulse between 50 and 90 beats per minute within 2 days prior to study entry
- Systolic blood pressure between 85 and 150 mmHg and diastolic blood pressure between 45 and 90 mmHg within 2 days prior to study entry
- Electrocardiogram demonstrating normal sinus rhythm, normal conduction, and no clinically significant arrhythmias
- Medical history and brief physical examination demonstrating no clinically significant contraindications for study participation
You may not qualify if:
- History or evidence of seizures or brain injury
- Previous adverse reaction to methamphetamine
- Neurological or psychiatric disorders (e.g., psychosis, bipolar illness, or major depression)
- Organic brain disease or dementia
- History of any psychiatric disorder that requires ongoing treatment or that would make study compliance difficult
- History of suicide attempts within the 3 months prior to study entry
- Heart disease or high blood pressure
- Family history of early cardiovascular morbidity or mortality
- Untreated or unstable medical illness, including neuroendocrine, autoimmune, liver, kidney, or active infectious disease
- HIV infected
- AIDS-defining illness
- Currently taking antiretroviral medication
- Pregnant or breastfeeding
- Unwilling to use an adequate method of contraception for the duration of the study
- History of respiratory illness (e.g., asthma, chronic coughing, and wheezing)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California - Los Angeles
Los Angeles, California, 90024, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steve Shoptaw, PhD
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
September 8, 2005
First Posted
September 12, 2005
Study Start
May 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
January 12, 2017
Record last verified: 2009-09