Trial · NCT01811940
Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
NCT01811940, Phase 2, Phase 3, Completed, New York State Psychiatric Institute; results first posted 2018-10-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence. Trials, record NCT01811940. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01811940
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence
- NCT number
- NCT01811940
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 169 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Cocaine Dependence
- Interventions
- Adderall-ER, Topiramate, Placebo
- First posted
- 2013-03-15
- Last updated
- 2019-04-24
- Results first posted
- 2018-10-12
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Three Weeks of Cocaine Abstinence at End of Study | assessed during 14 weeks of trial, presented for last 3 weeks | The number of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at the end of the study. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB) and corroborated by the urine toxicology samples collected 3 times per week. |
| Secondary | Any Three Consecutive Weeks of Abstinence During Study | 14 weeks of study or length of study participation | The proportion of participants in each study arm achieving sustained cocaine abstinence for three consecutive weeks at any time during the 14 week trial. This will be measured by self reported cocaine use on the daily Time line Follow Back (TLFB)and corroborated by the urine toxicology samples collected 3 times per week. |
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 | Three Weeks of Cocaine Abstinence at End of Study | assessed during 14 weeks of trial, presented for last 3 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Any Three Consecutive Weeks of Abstinence During Study | 14 weeks of study or length of study participation | Participants | COUNT_OF_PARTICIPANTS |
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 |
|---|---|---|---|---|---|
| Three Weeks of Cocaine Abstinence at End of Study | Adderall-ER and Topiramate | 9 | Participants | ||
| Three Weeks of Cocaine Abstinence at End of Study | Placebo | 0 | Participants | ||
| Any Three Consecutive Weeks of Abstinence During Study | Adderall-ER and Topiramate | 14 | Participants | ||
| Any Three Consecutive Weeks of Abstinence During Study | Placebo | 4 | 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 | Adderall-ER and Topiramate | 64 | |
| Overall Study | STARTED | Placebo | 63 | |
| Overall Study | COMPLETED | Adderall-ER and Topiramate | 42 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Adderall-ER and Topiramate | 22 | |
| Overall Study | NOT COMPLETED | Placebo | 26 |
Source ClinicalTrials.gov
Adverse events38
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 | headache | General disorders | Adderall-ER and Topiramate | 9 | 64 | 9 |
| other | headache | General disorders | Placebo | 10 | 63 | 10 |
| other | insomnia | General disorders | Adderall-ER and Topiramate | 12 | 64 | 12 |
| other | insomnia | General disorders | Placebo | 6 | 63 | 6 |
| other | URI | Respiratory, thoracic and mediastinal disorders | Adderall-ER and Topiramate | 8 | 64 | 8 |
| other | URI | Respiratory, thoracic and mediastinal disorders | Placebo | 9 | 63 | 9 |
| other | increased blood pressure | Cardiac disorders | Adderall-ER and Topiramate | 10 | 64 | 10 |
| other | increased blood pressure | Cardiac disorders | Placebo | 5 | 63 | 5 |
| other | anorexia | Gastrointestinal disorders | Adderall-ER and Topiramate | 9 | 64 | 9 |
| other | anorexia | Gastrointestinal disorders | Placebo | 5 | 63 | 5 |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adderall-ER and Topiramate | 0 | 64 |
| Total, all-cause mortality | Placebo | 0 | 63 |
| Total, other adverse events | Adderall-ER and Topiramate | 52 | 64 |
| Total, other adverse events | Placebo | 44 | 63 |
| Total, serious adverse events | Adderall-ER and Topiramate | 2 | 64 |
| Total, serious adverse events | Placebo | 2 | 63 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01DA033310 | 1/2-Multicenter Trial of Combined Pharmacotherapy to Treat Cocaine Dependence | LEVIN, FRANCES RUDNICK | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE ON DRUG ABUSE | 2013 to 2015 |
Source NIH RePORTER
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adderall-ER and Topiramate vs Placebo: Three Weeks of Cocaine Abstinence at End of Study | Trial comparisons |
| Adderall-ER and Topiramate vs Placebo: Any Three Consecutive Weeks of Abstinence During Study | Trial comparisons |
| Adderall-ER and Topiramate vs Placebo: deaths from any cause | Trial comparisons |
| Adderall-ER and Topiramate 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/NCT01811940
GET https://conductscience.org/api/trials/v1/NCT01811940/events?page=2