Trial · NCT00421603
A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
NCT00421603, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2013-02-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence. Trials, record NCT00421603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00421603
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
- NCT number
- NCT00421603
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Cocaine Dependence
- Interventions
- Adderall-XR and Topiramate, Placebo
- First posted
- 2007-01-12
- Last updated
- 2019-04-24
- Results first posted
- 2013-02-28
- Limitations and caveats
The two-arm placebo controlled design does not allow us to address whether both medications are necessary for efficacy. Potential limited treatment masking that occurred when giving two medications with distinctive adverse effect profiles.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back | 3 weeks of abstinence during 14 weeks of trial or for length of participation | Cocaine use was assessed by using urine toxicology confirmed self-report. Self-reported cocaine use data was collected for each day of the study period by the Time Line Follow Back. Urine samples were collected three times per week. A week was considered abstinence if no cocaine use was self reported during that week and if all urine samples collected that week were negative for cocaine. If a patient achieved three continuous weeks of abstinence based on this criteria they were considered cocaine abstinent in terms of this outcome measure. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back | 3 weeks of abstinence during 14 weeks of trial or for length of participation | participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back | Adderall-XR and Topiramate | 13 | participants | ||
| Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back | Placebo | 7 | 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-XR and Topiramate | 39 | |
| Overall Study | STARTED | Placebo | 42 | |
| Overall Study | COMPLETED | Adderall-XR and Topiramate | 28 | |
| Overall Study | COMPLETED | Placebo | 30 | |
| Overall Study | NOT COMPLETED | Adderall-XR and Topiramate | 11 | |
| Overall Study | NOT COMPLETED | Placebo | 12 |
Source ClinicalTrials.gov
Adverse events24
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 | Insomnia | Psychiatric disorders | Adderall-XR and Topiramate | 16 | 39 | 16 |
| other | Insomnia | Psychiatric disorders | Placebo | 7 | 42 | 7 |
| other | Increased/decreased appetite | Metabolism and nutrition disorders | Adderall-XR and Topiramate | 17 | 39 | 17 |
| other | Increased/decreased appetite | Metabolism and nutrition disorders | Placebo | 4 | 42 | 4 |
| other | Fatigue | General disorders | Adderall-XR and Topiramate | 11 | 39 | 11 |
| other | Fatigue | General disorders | Placebo | 6 | 42 | 6 |
| other | GI upset | Gastrointestinal disorders | Adderall-XR and Topiramate | 11 | 39 | 11 |
| other | GI upset | Gastrointestinal disorders | Placebo | 5 | 42 | 5 |
| other | Headache | General disorders | Adderall-XR and Topiramate | 11 | 39 | 11 |
| other | Headache | General disorders | Placebo | 5 | 42 | 5 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adderall-XR and Topiramate | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Adderall-XR and Topiramate | 33 | 39 |
| Total, other adverse events | Placebo | 21 | 42 |
| Total, serious adverse events | Adderall-XR and Topiramate | 1 | 39 |
| Total, serious adverse events | Placebo | 1 | 42 |
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 |
|---|---|---|---|---|---|
| R01DA022217 | Combined Pharmacotherapies for Cocaine Dependence | LEVIN, FRANCES RUDNICK | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE ON DRUG ABUSE | 2006 to 2008 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adderall-XR and Topiramate vs Placebo: Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back | Trial comparisons |
| Adderall-XR 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/NCT00421603
GET https://conductscience.org/api/trials/v1/NCT00421603/events?page=2