Cocaine DependencePhase 1/2NCT00656357
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
A Phase 1/2 study testing SYN117 80 mg, SYN117 160 mg and Cocaine 10mg in people with Cocaine Dependence, run by Biotie Therapies Inc. at 1 site in United States.
Trial summary
This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- SYN117 80 mg, SYN117 160 mg and Cocaine 10mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to May 2009
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- essentially normal liver and kidney function blood tests
- ECG normal
- sign informed consent
- negative urine pregnancy test at screening and admission
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch (UTMB)
Galveston, Texas, 77555
About this study
Official title: 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
- Conditions
- Cocaine Dependence
- Being tested
- SYN117 Placebo, SYN117 80 mg, SYN117 160 mg, Cocaine 10mg, Cocaine 20mg
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYN117 PlaceboDrug
Placebo
SYN117 80 mgDrug
SYN117 80 mg
SYN117 160 mgDrug
SYN117 160 mg
Cocaine 10mgDrug
IV Cocaine 10mg
Cocaine 20mgDrug
IV Cocaine 20mg
Cocaine 40mgDrug
IV Cocaine 40mg
SalineDrug
IV Cocaine Placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo Receives: 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 Receives: Drug: SYN117 80 mg; Drug: SYN117 160 mg; Drug: Cocaine 10mg; Drug: Cocaine 20mg; Drug: Cocaine 40mg; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: inpatient 14 days with 2 week outpatient follow-up
Secondary outcomes (4)
Determine tolerability by measuring adverse events
Measured: inpatient 14 days, 2 weeks post followup visit
Determine subjective effects produced by self administration of cocaine or placebo
Measured: Days 4, 8, 12 and 13
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine
Measured: 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
Measured: Days 4, 8 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2008 (estimated)
- Study startJun 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotie Therapies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Stephen Bandak, MD, Study chair, Biotie Therapies Inc.F. Gerald Moeller, MD, Study chair, UTSW-HoustonKathryn Cunningham, PhD, Principal investigator, UTMB-Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00656357
- Sponsor's protocol ID
- SYN117-CL01
- Status last verified
- Aug 2017
- First submitted
- 4 Apr 2008
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine
- ClinicalTrials.gov ID
- NCT00656357
- Acronym / sponsor ID
- SYN117-CL01
- Conditions
- Cocaine Dependence
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Biotie Therapies Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2008 (actual)
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Placebo comparator | Drug: SYN117 Placebo, Drug: Cocaine 10mg, Drug: Cocaine 20mg, Drug: Cocaine 40mg, Drug: SalineSYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo |
| B | Experimental | Drug: SYN117 80 mg, Drug: SYN117 160 mg, Drug: Cocaine 10mg, Drug: Cocaine 20mg, Drug: Cocaine 40mg, Drug: SalineAscending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- non treatment seeking cocaine dependent
- English speaking
- meet DSM IV TR criteria for cocaine dependence
- pulse 50-90bpm
- systolic BP 85-140 mmHg
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYN117 PlaceboPlacebo | Drug | A |
| SYN117 80 mgSYN117 80 mg | Drug | B |
| SYN117 160 mgSYN117 160 mg | Drug | B |
| Cocaine 10mgIV Cocaine 10mg | Drug | A, B |
| Cocaine 20mgIV Cocaine 20mg | Drug | A, B |
| Cocaine 40mgIV Cocaine 40mg | Drug | A, B |
| SalineIV Cocaine Placebo | Drug | A, B |
Primary outcome
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
4 secondary outcomes
Determine tolerability by measuring adverse events
Time frame: inpatient 14 days, 2 weeks post followup visit
Determine subjective effects produced by self administration of cocaine or placebo
Time frame: Days 4, 8, 12 and 13
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine
Time frame: 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
Time frame: Days 4, 8 and 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Bandak, MD study chair
Biotie Therapies Inc.
F. Gerald Moeller, MD study chair
UTSW-Houston
Kathryn Cunningham, PhD principal investigator
UTMB-Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SYN117 80 mg, SYN117 160 mg and Cocaine 10mg in people with Cocaine Dependence, run by Biotie Therapies Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.