Cocaine DependencePhase 2NCT01704196
A Multi-Center Trial of Nepicastat for Cocaine Dependence
A Phase 2 study testing Nepicastat in people with Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 10 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Nepicastat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 179 participants
- Where
- 10 sitesUnited States
- Study dates
- Apr 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years of age
- Is seeking treatment for cocaine dependence
- Is able to understand and provide written informed consent
- Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
- If female, agrees to use an acceptable method of birth control
- Is, in the opinion of the Investigator, likely to complete the 11-week Treatment Phase of the study
Who cannot join
- Please contact the study site for more information
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Pacific Institute for Research and Evaluation
Albuquerque, New Mexico, 87102
Mountain Manor Treatment Center at Baltimore
Baltimore, Maryland, 21229
Cincinnati Addiction Research Center
Cincinnati, Ohio, 45220
VA Medical Center - Denver, CO
Denver, Colorado, 80220
Michael E. DeBakey VA Medical Center
Houston, Texas, 77030
Matrix Institute on Addictions
Los Angeles, California, 90016
Columbia University Medical Center
New York, New York, 10019
University of Pennsylvania - Treatment Research Center
Philadelphia, Pennsylvania, 19104
George E. Wahlen VA Medical Center
Salt Lake City, Utah, 84148
VA San Diego Healthcare System
San Diego, California, 92161
About this study
Official title: Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.
- Conditions
- Cocaine Dependence
- Being tested
- Nepicastat, Placebo
- 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.
NepicastatDrug
120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Nepicastat | Active comparator | Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks Receives: Drug: Nepicastat |
| Placebo | Placebo comparator | Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence (Weeks 10 - 11)
Number of subjects that abstained from cocaine from weeks 10 through 11
Measured: Weeks 10 - 11
Secondary outcomes (1)
Reduction in Use (Weeks 1 - 11)
Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11
Measured: Baseline through week 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startApr 2013
- Primary completionAug 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704196
- Sponsor's protocol ID
- NIDA/VA CS#1031
- Status last verified
- Apr 2017
- First submitted
- 17 Sep 2012
- Last updated
- 18 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Trial of Nepicastat for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT01704196
- Acronym / sponsor ID
- NIDA/VA CS#1031
- Conditions
- Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Study start
- Apr 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Oct 2012 (estimated)
- Results
- Posted 18 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nepicastat | Active comparator | Drug: NepicastatNepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule containing 100mg riboflavin (once per day) for 11 weeks. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be at least 18 years of age
- Is seeking treatment for cocaine dependence
- Is able to understand and provide written informed consent
- Has completed all psychological assessments and procedures required during the 7 - 14 day screening period
- If female, agrees to use an acceptable method of birth control
Key exclusion criteria (1 listed)
- Please contact the study site for more information
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 |
|---|---|---|
| Nepicastat120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks. | Drug | Nepicastat |
| Placebo | Drug | Placebo |
Primary outcome
Abstinence (Weeks 10 - 11)
Time frame: Weeks 10 - 11
Number of subjects that abstained from cocaine from weeks 10 through 11
1 secondary outcome
Reduction in Use (Weeks 1 - 11)
Time frame: Baseline through week 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nepicastat in people with Cocaine Dependence, run by National Institute on Drug Abuse (NIDA) at 10 sites 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 6 inclusion and 1 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 18 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 18 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Abstinence (Weeks 10 - 11) (time frame: Weeks 10 - 11). 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 18 May 2017.