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Completed

NCT Number: NCT00158210

Rivastigmine For Methamphetamine Dependent Individuals

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California - Los Angeles

Los Angeles, California, 90024, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine

Drug

Primary outcomes

  1. Methamphetamine abstinence

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Collaborators

  • University of California, Los Angeles

Registry information

Official study title

Double-Blind Randomized Placebo Controlled Trial of Rivastigmine (Excelon) as a Potential Medication for Methamphetamine Abuse

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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