NCT00158210

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2006

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
8 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

September 1, 2009

Enrollment Period

10 months

First QC Date

September 8, 2005

Last Update Submit

January 11, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Methamphetamine abstinence

Interventions

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California - Los Angeles

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylcarbamatesCarbamatesAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Steve Shoptaw, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

May 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

January 12, 2017

Record last verified: 2009-09

Locations