Trial · NCT01704196
A Multi-Center Trial of Nepicastat for Cocaine Dependence
NCT01704196, Phase 2, Completed, National Institute on Drug Abuse (NIDA); results first posted 2017-05-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Multi-Center Trial of Nepicastat for Cocaine Dependence. Trials, record NCT01704196. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01704196
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Multi-Center Trial of Nepicastat for Cocaine Dependence
- NCT number
- NCT01704196
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 179 participants, actual
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Conditions
- Cocaine Dependence
- Interventions
- Nepicastat, Placebo
- First posted
- 2012-10-11
- Last updated
- 2017-05-18
- Results first posted
- 2017-05-18
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Abstinence (Weeks 10 - 11) | Weeks 10 - 11 | Number of subjects that abstained from cocaine from weeks 10 through 11 |
| Secondary | Reduction in Use (Weeks 1 - 11) | Baseline through week 11 | Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11 |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Abstinence (Weeks 10 - 11) | Weeks 10 - 11 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Reduction in Use (Weeks 1 - 11) | Baseline through week 11 | participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Abstinence (Weeks 10 - 11) | Nepicastat | 4 | Participants | ||
| Abstinence (Weeks 10 - 11) | Placebo | 7 | Participants | ||
| Reduction in Use (Weeks 1 - 11) | Nepicastat | 13 | participants | ||
| Reduction in Use (Weeks 1 - 11) | Placebo | 20 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nepicastat | 90 | |
| Overall Study | STARTED | Placebo | 89 | |
| Overall Study | COMPLETED | Nepicastat | 71 | |
| Overall Study | COMPLETED | Placebo | 65 | |
| Overall Study | NOT COMPLETED | Nepicastat | 19 | |
| Overall Study | NOT COMPLETED | Placebo | 24 |
Source ClinicalTrials.gov
Adverse events52
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Nepicastat | 6 | 90 | 6 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 7 | 89 | 10 |
| other | Nausea | Gastrointestinal disorders | Nepicastat | 6 | 90 | 7 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 89 | 5 |
| other | Headache | Nervous system disorders | Nepicastat | 16 | 90 | 20 |
| other | Headache | Nervous system disorders | Placebo | 11 | 89 | 17 |
| other | Rash | Skin and subcutaneous tissue disorders | Nepicastat | 7 | 90 | 8 |
| other | Rash | Skin and subcutaneous tissue disorders | Placebo | 2 | 89 | 2 |
| other | Hypertension | Vascular disorders | Nepicastat | 6 | 90 | 9 |
| other | Hypertension | Vascular disorders | Placebo | 7 | 89 | 9 |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nepicastat | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Nepicastat | 80 | 90 |
| Total, other adverse events | Placebo | 67 | 89 |
| Total, serious adverse events | Nepicastat | 8 | 90 |
| Total, serious adverse events | Placebo | 2 | 89 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nepicastat vs Placebo: Reduction in Use (Weeks 1 - 11) | Trial comparisons |
| Nepicastat vs Placebo: Abstinence (Weeks 10 - 11) | Trial comparisons |
| Nepicastat vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01704196
GET https://conductscience.org/api/trials/v1/NCT01704196/events?page=2