Perindopril-Methamphetamine Interaction Study

Status Completed

Clinical Trial Summary

Due to its ease of synthesis and powerful psychostimulant effects, abuse of methamphetamine has increased rapidly over the last decade. No medications are currently approved for the treatment of methamphetamine dependence or withdrawal. The purpose of this study is to determine whether perindopril, an angiotensin converting enzyme (ACE) inhibitor, modifies cardiovascular responses and adverse events when taking methamphetamines.

Clinical Trial Description

Methamphetamine is a commonly abused drug associated with dopamine neurotoxicity. It damages brain cells that contain dopamine, which can result in Parkinson-like symptoms, such as muscle rigidity, tremors, and limited movement. Because ACE inhibitors have the potential to reverse methamphetamine's neurotoxicity effects, they may prove useful as treatment drugs. Perindopril is an antihypertensive medication that demonstrates greater activity in the central nervous system than other ACE inhibitors. The purpose of this study is to determine whether perindopril modifies cardiovascular responses and adverse events during methamphetamine administration. In addition, this study will determine whether perindopril alters methamphetamine pharmacokinetics and its reinforcing effects, thus making perindopril a possible treatment option.

Participants in this double-blind, placebo-controlled trial will initially receive baseline infusions of methamphetamine. Those that tolerate the baseline methamphetamine will be randomly assigned to receive either perindopril or placebo. Perindopril will be administered at a dose of either 2, 4, 8, or 16 mg per day over a 5-day inpatient period. On Days 3 and 5, participants will receive infusions of 15 and 30 mg of intravenous methamphetamine. Each methamphetamine infusion will be preceded or followed by an intravenous infusion of saline. Heart rate and electrocardiograms will be continuously monitored. Participants will be discharged 2 days after the final doses of methamphetamine and perindopril, and will return approximately 1 week later (Day 18) for an additional evaluation. ;

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00249665
Study type	Interventional
Source	National Institute on Drug Abuse (NIDA)
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	August 2004
Completion date	January 2008

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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.