Trial · NCT01486810
Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
NCT01486810, Phase 1, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2018-07-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence. Trials, record NCT01486810. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01486810
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open-Label Pilot Study of Lisdexamfetamine for Cocaine Dependence
- NCT number
- NCT01486810
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 17 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Cocaine Dependence
- Interventions
- Lisdexamfetamine, medication management
- First posted
- 2011-12-07
- Last updated
- 2019-04-24
- Results first posted
- 2018-07-11
- Limitations and caveats
- As this was an open label trial, future studies should evaluate lisdexamfetamine for the treatment cocaine use disorder under double-blind conditions.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. | during 1 week of study participation | Number of participants achieving and maintained for a seven day period during the trial on the maximum daily dose of 140 mg.. |
| Primary | Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial. | during 8 weeks of trial or length of participation | The mean maximum daily dose of lisdexamfetamine that was maintained for at least 1 week of trial. |
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 | Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. | during 1 week of study participation | Although 17 participants were enrolled, one participant was lost to follow-up without any post-enrollment study data, therefore 16 participants were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial. | during 8 weeks of trial or length of participation | data available for 16 participants. | mgs/day | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Maintained on the Maximum Lisdexamfetamine Daily Dose. | Lisdexamfetamine and Medication Management | 12 | Participants | ||
| Mean Maximum Maintained Dose of Lisdexamfetamine for at Least 1 Week of Trial. | Lisdexamfetamine and Medication Management | 118.1 | Standard Deviation 40.4 | mgs/day |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Lisdexamfetamine and Medication Management | 17 | |
| Overall Study | COMPLETED | Lisdexamfetamine and Medication Management | 9 | |
| Overall Study | NOT COMPLETED | Lisdexamfetamine and Medication Management | 8 |
Source ClinicalTrials.gov
Adverse events13
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 | abdominal pain | Gastrointestinal disorders | Lisdexamfetamine and Medication Management | 1 | 16 | 1 |
| other | appetite change | General disorders | Lisdexamfetamine and Medication Management | 6 | 16 | 6 |
| other | constipation | Gastrointestinal disorders | Lisdexamfetamine and Medication Management | 1 | 16 | 1 |
| other | increased heart rate | Cardiac disorders | Lisdexamfetamine and Medication Management | 2 | 16 | 2 |
| other | diarrhea | Gastrointestinal disorders | Lisdexamfetamine and Medication Management | 2 | 16 | 2 |
| other | dry mouth | General disorders | Lisdexamfetamine and Medication Management | 2 | 16 | 2 |
| other | headache | General disorders | Lisdexamfetamine and Medication Management | 1 | 16 | 1 |
| other | increased blood pressure | Cardiac disorders | Lisdexamfetamine and Medication Management | 1 | 16 | 1 |
| other | insomnia | General disorders | Lisdexamfetamine and Medication Management | 3 | 16 | 3 |
| other | jittery | General disorders | Lisdexamfetamine and Medication Management | 5 | 16 | 5 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lisdexamfetamine and Medication Management | ||
| Total, other adverse events | Lisdexamfetamine and Medication Management | 13 | 16 |
| Total, serious adverse events | Lisdexamfetamine and Medication Management | 0 | 16 |
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 |
|---|---|---|---|---|---|
| P50DA009236 | Novel Medication Approaches for Substance Abuse | KLEBER, HERBERT DAVID | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE ON DRUG ABUSE | 1994 to 2013 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01486810
GET https://conductscience.org/api/trials/v1/NCT01486810/registered