Rivastigmine For Methamphetamine Dependent Individuals

National Institutes of Health (NIH)

Status and phase

Completed

Phase 1

Conditions

Substance-Related Disorders

Treatments

Drug: Rivastigmine

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00158210

P50DA018185 (U.S. NIH Grant/Contract)

DPMCDA

NIDA-18185-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment

18 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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