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Rivastigmine For Methamphetamine Dependent Individuals

Primary Purpose

Substance-Related Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Rivastigmine
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance-Related Disorders

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts 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

Sites / Locations

  • University of California - Los Angeles

Outcomes

Primary Outcome Measures

Methamphetamine abstinence

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT00158210
Brief Title
Rivastigmine For Methamphetamine Dependent Individuals
Official Title
Double-Blind Randomized Placebo Controlled Trial of Rivastigmine (Excelon) as a Potential Medication for Methamphetamine Abuse
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
University of California, Los Angeles

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance-Related Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rivastigmine
Primary Outcome Measure Information:
Title
Methamphetamine abstinence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Shoptaw, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

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Rivastigmine For Methamphetamine Dependent Individuals

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