Trial · NCT00142818
Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence
NCT00142818, Phase 2, Completed, Kyle Kampman; results first posted 2014-08-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence. Trials, record NCT00142818. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00142818
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence
- NCT number
- NCT00142818
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 164 participants, actual
- Lead sponsor
- Kyle Kampman
- Conditions
- Alcohol-Related Disorders, Alcoholism, Cocaine-Related Disorders
- Interventions
- Naltrexone, Modafinil, Placebo
- First posted
- 2005-09-02
- Last updated
- 2020-07-16
- Results first posted
- 2014-08-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14) | 13 weeks | |
| Primary | Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14 | 13 weeks |
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 | Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14) | 13 weeks | number of cocaine negative urine samples | MEAN | |
| PRIMARY | Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14 | 13 weeks | mean percentage of days | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14) | ModNal | 9.3 | Standard Deviation 8.4 | number of cocaine negative urine samples | |
| Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14) | Naltrexone and Placebo | 7.2 | Standard Deviation 8.1 | number of cocaine negative urine samples | |
| Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14) | Modafinil and Placebo | 10.1 | Standard Deviation 9.4 | number of cocaine negative urine samples | |
| Cocaine Use (Measured by Timeline Follow Back and Urine Screen From Week 2-week 14) | Double Placebo | 10.5 | Standard Deviation 9.9 | number of cocaine negative urine samples | |
| Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14 | Modafinil Plus Naltrexone | 34.7 | Standard Error 4.4 | mean percentage of days | |
| Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14 | Naltrexone | 35.1 | Standard Error 4.2 | mean percentage of days | |
| Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14 | Modafinil | 33.6 | Standard Error 4.2 | mean percentage of days | |
| Percent Days of Heavy Drinking (Measured by Timeline Follow Back Starting at Week Two Through Week 14 | Placebo | 33.8 | Standard Error 4.3 | mean percentage of days |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ModNal | 45 | |
| Overall Study | STARTED | Naltrexone and Placebo | 40 | |
| Overall Study | STARTED | Modafinil and Placebo | 37 | |
| Overall Study | STARTED | Double Placebo | 42 | |
| Overall Study | COMPLETED | ModNal | 28 | |
| Overall Study | COMPLETED | Naltrexone and Placebo | 19 | |
| Overall Study | COMPLETED | Modafinil and Placebo | 24 | |
| Overall Study | COMPLETED | Double Placebo | 20 | |
| Overall Study | NOT COMPLETED | ModNal | 17 | |
| Overall Study | NOT COMPLETED | Naltrexone and Placebo | 21 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse 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 | Nausea | Gastrointestinal disorders | ModNal | 11 | 45 | |
| other | Nausea | Gastrointestinal disorders | Naltrexone and Placebo | 10 | 40 | |
| other | Nausea | Gastrointestinal disorders | Modafinil and Placebo | 8 | 37 | |
| other | Nausea | Gastrointestinal disorders | Double Placebo | 4 | 42 | |
| other | Anxiety | Psychiatric disorders | ModNal | 9 | 45 | |
| other | Anxiety | Psychiatric disorders | Naltrexone and Placebo | 2 | 40 | |
| other | Anxiety | Psychiatric disorders | Modafinil and Placebo | 7 | 37 | |
| other | Anxiety | Psychiatric disorders | Double Placebo | 0 | 42 | |
| serious | Hospitalization | General disorders | ModNal | 7 | 45 | 9 |
| serious | Hospitalization | General disorders | Naltrexone and Placebo | 3 | 40 | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ModNal | ||
| Total, all-cause mortality | Naltrexone and Placebo | ||
| Total, all-cause mortality | Modafinil and Placebo | ||
| Total, all-cause mortality | Double Placebo | ||
| Total, other adverse events | ModNal | 11 | 45 |
| Total, other adverse events | Naltrexone and Placebo | 10 | 40 |
| Total, other adverse events | Modafinil and Placebo | 8 | 37 |
| Total, other adverse events | Double Placebo | 4 | 42 |
| Total, serious adverse events | ModNal | 11 | 45 |
| Total, serious adverse events | Naltrexone and Placebo | 6 | 40 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 |
|---|---|---|---|---|---|
| P50DA012756 | Innovative Approaches for Cocaine Pharmacotherapy | KAMPMAN, KYLE MATTHEW | UNIVERSITY OF PENNSYLVANIA | NATIONAL INSTITUTE ON DRUG ABUSE | 1999 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/NCT00142818
GET https://conductscience.org/api/trials/v1/NCT00142818/events?page=2