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

NCT00656357 | Completed Phase 1 DMC

• 1 other identifier: SYN117-CL01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

A

PLACEBO COMPARATOR

SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo

Drug: SYN117 Placebo; Drug: Cocaine 10mg; Drug: Cocaine 20mg; Drug: Cocaine 40mg; Drug: Saline

B

EXPERIMENTAL

Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo

Drug: SYN117 80 mg; Drug: SYN117 160 mg; Drug: Cocaine 10mg; Drug: Cocaine 20mg; Drug: Cocaine 40mg; Drug: Saline

Interventions

SYN117 Placebo DRUG

Placebo

A

SYN117 80 mg DRUG

SYN117 80 mg

B

SYN117 160 mg DRUG

SYN117 160 mg

B

Cocaine 10mg DRUG

IV Cocaine 10mg

A; B

Cocaine 20mg DRUG

IV Cocaine 20mg

A; B

Cocaine 40mg DRUG

IV Cocaine 40mg

A; B

Saline DRUG

IV Cocaine Placebo

A; B

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biotie Therapies Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Cocaine-Related Disorders

Interventions

Cocaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Stephen Bandak, MD

  Biotie Therapies Inc.

  STUDY CHAIR

• F. Gerald Moeller, MD

  UTSW-Houston

  STUDY CHAIR

• Kathryn Cunningham, PhD

  UTMB-Galveston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 11, 2008
• Study Start: June 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 17, 2018

Record last verified: 2017-08

Locations

US (1)