Rivastigmine as a Treatment for Methamphetamine Dependence

Status Completed

Clinical Trial Summary

To study the effects of treatment with rivastigmine on craving produced by experimental administration of methamphetamine.

Clinical Trial Description

We recently completed a double-blind placebo-controlled human laboratory study demonstrating that treatment with a low dose of the acetylcholinesterase (AChE) inhibitor rivastigmine reduced methamphetamine (METH)-induced craving (see Preliminary Studies, Fig. 2). This finding is consistent with the preclinical report indicating that the AChE inhibitor donepezil reduced METH-seeking behavior in rats following exposure to a non-contingent dose of METH (Hiranita et al. 2006). To extend our clinical findings, we propose a 3-year human laboratory study to evaluate effects of higher doses of rivastigmine on METH-induced craving and on self-administration of METH. Our recently completed work indicates that 3mg rivastigmine attenuated METH-induced craving in the laboratory. Given that higher dosages of this produce greater inhibition of nicotinic acetylcholine (ACh) receptors (in the treatment of Alzheimer's disease), it is reasonable to predict that 6mg and 12mg will have more pronounced effects on craving and other measures of reinforcement. This human laboratory study is a critical next step in the evaluation of rivastigmine as a potential treatment for METH dependence. We propose to include only participants exhibiting METH-induced craving by screening potential participants prior to admission (criterion based upon Preliminary Studies, Fig. 5). Selection of participants demonstrating METH-induced craving will facilitate assessment of effects of rivastigmine on craving. The project has the following objectives:

Primary Objective: To characterize the effects of treatment with rivastigmine (0, 3, and 6 mg) on craving produced by experimental administration of METH (0, 15 and 30mg, IV).

Secondary Objective: To characterize the effects of treatment with rivastigmine (0, 3, and 6 mg) on choices for METH exhibited in a self-administration paradigm (0 and 5mg, IV). ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01073319
Study type	Interventional
Source	Baylor College of Medicine
Contact
Status	Completed
Phase	Phase 1
Start date	July 2009
Completion date	July 2010

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04070521` - EEG Monitoring in the Emergency Department
Completed	`NCT00729391` - Women-Focused HIV Prevention in the Western Cape	Phase 2/Phase 3
Active, not recruiting	`NCT03129334` - Preventing Prescription Drug Abuse in Middle School Students	N/A
Completed	`NCT02733003` - Implementation Research for Vulnerable Women in South Africa	N/A
Completed	`NCT02573948` - Feasibility of Interventions on People Who Inject Drugs in Vietnam
Completed	`NCT02282306` - Phone Interview to Prevent Recurring Opioid Overdoses	N/A
Withdrawn	`NCT01523444` - Advancing Adolescent Screening and Brief Intervention Protocols in Primary Care Settings	Phase 3
Withdrawn	`NCT01847300` - cSBI-M for Young Military Personnel	N/A
Completed	`NCT01481428` - Reducing High Risk Behavior in Treatment Court	Phase 1
Completed	`NCT01591239` - Home-Based Program to Help Parents of Drug Abusing Adolescents	N/A
Completed	`NCT01601743` - Exercise as a Behavioral Treatment for Cocaine Dependence	N/A
Active, not recruiting	`NCT00847548` - Treatment of Intimate Partner Violence and Substance Abuse in a Forensic Setting	N/A
Withdrawn	`NCT01228890` - Primary Care Internet-Based Depression Prevention for Adolescents (CATCH-IT)	Phase 3
Completed	`NCT01614015` - Building Outcomes With Observation-Based Supervision: An FFT Effectiveness Trial	Phase 2
Completed	`NCT01621334` - The Men's Domestic Abuse Check-Up Engages Adult Men Concerned About Their Abusive Behavior and Alcohol or Drug Use	Phase 1
Completed	`NCT00717444` - Healthy Activities for Prize Incentives	N/A
Completed	`NCT00841711` - Transitions: Linkages From Jail To Community	N/A
Completed	`NCT00685074` - Computer-based Brief Intervention for Perinatal Substance Abuse	Phase 1/Phase 2
Completed	`NCT01188434` - Integrating Interventions for Maternal Substance Abuse	Phase 1
Completed	`NCT01465490` - Monitoring and Feedback in Substance Abuse Treatment	Phase 1/Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.