Rivastigmine For Methamphetamine Dependent Individuals

• Sponsor: National Institute on Drug Abuse (NIDA) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00158210
• Collaborator: University of California, Los Angeles (Other)
• Enrollment: 18
• Location: 1
• Duration (Months): 10
• Patients Per Site Per Month: 1.8

Study Details

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.

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 Design

• Study Type: Interventional
• 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 1, 2006
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. Methamphetamine abstinence []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00158210
• Other Study ID Numbers: NIDA-18185-1; P50DA018185; DPMCDA
• First Posted: Sep 12, 2005
• Last Update Posted: Jan 12, 2017
• Last Verified: Sep 1, 2009

• Additional relevant MeSH terms: Substance-Related Disorders; Rivastigmine

Study Results

No Results Posted as of Jan 12, 2017