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

Primary Purpose

Cocaine Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SYN117 Placebo
SYN117 80 mg
SYN117 160 mg
Cocaine 10mg
Cocaine 20mg
Cocaine 40mg
Saline
Sponsored by
Biotie Therapies Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cocaine Dependence

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Medical Branch (UTMB)

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

A

B

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Determine tolerability by measuring adverse events
Determine subjective effects produced by self administration of cocaine or placebo
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine
Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine

Full Information

First Posted
April 4, 2008
Last Updated
August 15, 2018
Sponsor
Biotie Therapies Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00656357
Brief Title
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
Official Title
A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2008 (Actual)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biotie Therapies Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cocaine Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Arm Title
B
Arm Type
Experimental
Arm Description
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Intervention Type
Drug
Intervention Name(s)
SYN117 Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
SYN117 80 mg
Intervention Description
SYN117 80 mg
Intervention Type
Drug
Intervention Name(s)
SYN117 160 mg
Intervention Description
SYN117 160 mg
Intervention Type
Drug
Intervention Name(s)
Cocaine 10mg
Intervention Description
IV Cocaine 10mg
Intervention Type
Drug
Intervention Name(s)
Cocaine 20mg
Intervention Description
IV Cocaine 20mg
Intervention Type
Drug
Intervention Name(s)
Cocaine 40mg
Intervention Description
IV Cocaine 40mg
Intervention Type
Drug
Intervention Name(s)
Saline
Intervention Description
IV Cocaine Placebo
Primary Outcome Measure Information:
Title
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.
Time Frame
inpatient 14 days with 2 week outpatient follow-up
Secondary Outcome Measure Information:
Title
Determine tolerability by measuring adverse events
Time Frame
inpatient 14 days, 2 weeks post followup visit
Title
Determine subjective effects produced by self administration of cocaine or placebo
Time Frame
Days 4, 8, 12 and 13
Title
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine
Time Frame
Days 3 and 11
Title
Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine
Time Frame
Days 4, 8 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Bandak, MD
Organizational Affiliation
Biotie Therapies Inc.
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
F. Gerald Moeller, MD
Organizational Affiliation
UTSW-Houston
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Kathryn Cunningham, PhD
Organizational Affiliation
UTMB-Galveston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Medical Branch (UTMB)
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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