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

A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine

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

Study Overview

• Status: Completed
• Conditions: Cocaine Dependence
• Intervention / Treatment: Drug: SYN117 Placebo; Drug: Cocaine 10mg; Drug: Cocaine 20mg; Drug: Cocaine 40mg; Drug: Saline; Drug: SYN117 80 mg; Drug: SYN117 160 mg

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch (UTMB)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• non treatment seeking cocaine dependent
• English speaking
• meet DSM IV TR criteria for cocaine dependence
• pulse 50-90bpm
• systolic BP 85-140 mmHg
• diastolic BP 45-90 mmHg
• essentially normal liver and kidney function blood tests
• ECG normal
• sign informed consent
• negative urine pregnancy test at screening and admission

Exclusion Criteria:

• history or evidence of seizure disorder or brain injury
• previous medically adverse reaction to cocaine, including loss of consciousness, chest pain or epileptic seizure
• neurological disorders, organic brain disease, dementia
• psychiatric disorders such as psychosis, schizophrenia, bipolar disorder, major depression
• history of suicide attempts within past 3 months or suicidal ideation/plan
• history of clinically significant heart disease or hypertension
• family history in 1st degree relatives of early cardiovascular morbidity or mortality
• untreated or unstable medical conditions
• positive HIV test
• pregnant or nursing
• have asthma or are currently using alpha, beta agonists or theophylline or other sympathomimetics
• test positive for other drugs of abuse with the exception of cocaine, cocaine metabolites or marijuana
• any other illness, condition or use of psychotropic medications which preclude safe/successful completion of the study
• currently on parole

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: A; SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo	Drug: SYN117 Placebo; Placebo; Drug: Cocaine 10mg; IV Cocaine 10mg; Drug: Cocaine 20mg; IV Cocaine 20mg; Drug: Cocaine 40mg; IV Cocaine 40mg; Drug: Saline; IV Cocaine Placebo
Experimental: B; Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo	Drug: Cocaine 10mg; IV Cocaine 10mg; Drug: Cocaine 20mg; IV Cocaine 20mg; Drug: Cocaine 40mg; IV Cocaine 40mg; Drug: Saline; IV Cocaine Placebo; Drug: SYN117 80 mg; SYN117 80 mg; Drug: SYN117 160 mg; SYN117 160 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Determine the safety of treatment with SYN117 in cocaine-dependent volunteers by measuring hemodynamic and subjective effects of administration of ascending doses of cocaine(10mg, 20mg, 40mg)and placebo during treatment with ascending doses of SYN117.	inpatient 14 days with 2 week outpatient follow-up

Secondary Outcome Measures

Outcome Measure	Time Frame
Determine tolerability by measuring adverse events	inpatient 14 days, 2 weeks post followup visit
Determine subjective effects produced by self administration of cocaine or placebo	Days 4, 8, 12 and 13
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine	Days 3 and 11
Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine	Days 4, 8 and 12

Collaborators and Investigators

• Sponsor: Biotie Therapies Inc.
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Study Chair: Stephen Bandak, MD, Biotie Therapies Inc.; Study Chair: F. Gerald Moeller, MD, UTSW-Houston; Principal Investigator: Kathryn Cunningham, PhD, UTMB-Galveston

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2008
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 11, 2008

Study Record Updates

• Last Update Posted (Actual): August 17, 2018
• Last Update Submitted That Met QC Criteria: August 15, 2018
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Anesthetics, Local; Dopamine Uptake Inhibitors; Vasoconstrictor Agents; Cocaine
• Other Study ID Numbers: SYN117-CL01