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Rivastigmine For Methamphetamine Dependent Individuals

This study has been completed.
Sponsor:
Collaborator:
University of California, Los Angeles
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00158210
First received: September 8, 2005
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  Purpose

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 Intervention Phase
Substance-Related Disorders
 Drug: Rivastigmine
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Double-Blind Randomized Placebo Controlled Trial of Rivastigmine (Excelon) as a Potential Medication for Methamphetamine Abuse

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Methamphetamine abstinence

Enrollment: 18
Study Start Date: May 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158210

Locations
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
Investigators
Principal Investigator: Steve Shoptaw, PhD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Dr Steven Shoptaw, UCLA Department of Family Medicine
ClinicalTrials.gov Identifier: NCT00158210     History of Changes
Other Study ID Numbers: NIDA-18185-1, P50-DA018185, DPMCDA
Study First Received: September 8, 2005
Last Updated: September 3, 2009
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Substance-Related Disorders
Mental Disorders
Methamphetamine
Amphetamine
Rivastigmine
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
Cholinesterase Inhibitors
Enzyme Inhibitors
Cholinergic Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013