Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers

Summary

This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects

Conditions

• Cocaine Dependence

Interventions

DRUG

SYN117 Placebo

Placebo

DRUG

SYN117 80 mg

SYN117 80 mg

DRUG

SYN117 160 mg

SYN117 160 mg

DRUG

Cocaine 10mg

IV Cocaine 10mg

DRUG

Cocaine 20mg

IV Cocaine 20mg

DRUG

Cocaine 40mg

IV Cocaine 40mg

DRUG

Saline

IV Cocaine Placebo

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Biotie Therapies Inc.

  lead INDUSTRY

Principal Investigators

• Stephen Bandak, MD · Biotie Therapies Inc.

• F. Gerald Moeller, MD · UTSW-Houston

• Kathryn Cunningham, PhD · UTMB-Galveston

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-06-30

Primary Completion

2009-05-31

Completion

2009-05-31

Countries

• United States

Study Locations