Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Placebo Comparator | SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo |
|
| B | Experimental | Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SYN117 Placebo | Drug | Placebo |
| |
| SYN117 80 mg |
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Bandak, MD | Biotie Therapies Inc. | Study Chair |
| F. Gerald Moeller, MD | UTSW-Houston | Study Chair |
| Kathryn Cunningham, PhD | UTMB-Galveston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Medical Branch (UTMB) | Galveston | Texas | 77555 | United States |
Not provided
| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003042 | Cocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
SYN117 80 mg |
|
| SYN117 160 mg | Drug | SYN117 160 mg |
|
| Cocaine 10mg | Drug | IV Cocaine 10mg |
|
| Cocaine 20mg | Drug | IV Cocaine 20mg |
|
| Cocaine 40mg | Drug | IV Cocaine 40mg |
|
| Saline | Drug | IV Cocaine Placebo |
|
| 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 |
| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |