Rivastigmine For Methamphetamine Dependent Individuals
Status: | Completed |
---|---|
Conditions: | Psychiatric |
Therapuetic Areas: | Psychiatry / Psychology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 1/13/2017 |
Start Date: | May 2006 |
End Date: | March 2007 |
Double-Blind Randomized Placebo Controlled Trial of Rivastigmine (Excelon) as a Potential Medication for Methamphetamine Abuse
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.
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.
Methamphetamine is a powerful stimulant that affects the central nervous system. Chronic
methamphetamine use often leads to psychotic behavior. Rivastigmine is an
acetylcholinesterase inhibitor that is currently approved to treat Alzheimer's-related
dementia. The purpose of this study is to assess the efficacy of rivastigmine in treating
methamphetamine dependent individuals.
Participants will be randomly assigned to either one of two dose levels of rivastigmine or
placebo for 12 weeks. Participants will be assessed for cardiovascular, subjective, and
reinforcing effects that are produced by methamphetamine. All participants will partake in
contingency management sessions through Week 4.
methamphetamine use often leads to psychotic behavior. Rivastigmine is an
acetylcholinesterase inhibitor that is currently approved to treat Alzheimer's-related
dementia. The purpose of this study is to assess the efficacy of rivastigmine in treating
methamphetamine dependent individuals.
Participants will be randomly assigned to either one of two dose levels of rivastigmine or
placebo for 12 weeks. Participants will be assessed for cardiovascular, subjective, and
reinforcing effects that are produced by methamphetamine. All participants will partake in
contingency management sessions through Week 4.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
- Currently using alpha or beta agonists, theophylline, or other sympathomimetics
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