NCT01601717

RTI-336 as a Treatment for Methamphetamine Dependence

RTI-336 for Methamphetamine Dependence

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Baylor College of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of RTI-336 as a treatment for methamphetamine (METH) dependence in non-treatment-seeking METH-dependent volunteers.

Detailed description

Methamphetamine (METH) is a highly addictive stimulant and acute exposure causes dopamine (DA) release and stimulates midbrain reward centers. The proposed work represents an important research effort with considerable public health significance in that it will evaluate a compound targeted specifically at DA transporter (DAT) inhibition for the treatment of METH dependence. The knowledge gained may ultimately support development and implementation of evidence-based treatments for METH dependence, a drug abuse problem with tremendous public health impact. One therapeutic strategy is to develop and test compounds that normalize (increase) DA to determine if treatment with these drugs reduces METH use. A similar approach has been proposed as a treatment for cocaine dependence (Howell and Wilcox 2001; Mello and Negus 1996), another disorder associated with abnormally low DA activity (Martinez et al. 2007). In an effort to identify a DAT selective inhibitor, a number of 3-phenyltropane analogs were synthesized by RTI International. Among these, preclinical studies have shown that RTI-336 produced cocaine-like discriminative stimulus effects and reduced cocaine self-administration in rats, and produced dose-dependent suppression of cocaine self-administration in rhesus monkeys. RTI-336 recently received IND-approval (75,778) for preliminary safety testing in healthy male volunteers, and is scheduled to be completed by February 2009. Subsequent to this effort, RTI-336 will be evaluated in a phase I trial involving cocaine-dependent volunteers. The current application puts forth, for the first time, a proposal to evaluate the preliminary efficacy of this very promising candidate medication in non-treatment-seeking METH-dependent volunteers.

Conditions

• Methamphetamine Dependence
• Substance Abuse
• Methamphetamine Abuse

Interventions

Type	Name	Description
DRUG	RTI-336	Four medication dosage groups (0 mg, 1 mg, 12 mg, 20 mg) administered in the form of a pill once per day for 10 days.
DRUG	Placebo	Matching placebo pill administered once per day for 10 days.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2012-05-18
• Last updated: 2012-05-18