Rivastigmine For Methamphetamine Dependent Individuals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158210
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 12, 2017
University of California, Los Angeles
Information provided by:
National Institute on Drug Abuse (NIDA)

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.

Condition or disease Intervention/treatment Phase
Substance-Related Disorders Drug: Rivastigmine Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Double-Blind Randomized Placebo Controlled Trial of Rivastigmine (Excelon) as a Potential Medication for Methamphetamine Abuse
Study Start Date : May 2006
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

Primary Outcome Measures :
  1. Methamphetamine abstinence

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158210

United States, California
University of California - Los Angeles
Los Angeles, California, United States, 90024
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
University of California, Los Angeles
Principal Investigator: Steve Shoptaw, PhD University of California, Los Angeles

Responsible Party: Dr Steven Shoptaw, UCLA Department of Family Medicine Identifier: NCT00158210     History of Changes
Other Study ID Numbers: NIDA-18185-1
P50DA018185 ( U.S. NIH Grant/Contract )
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: September 2009

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents