Trial · NCT00654953
Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans
NCT00654953, Phase 2, Completed, University of Arkansas; results first posted 2011-04-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans. Trials, record NCT00654953. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00654953
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Efficacy of Sertraline Augmented With Gabapentin in Depressed, Recently Abstinent Cocaine-dependent Humans
- NCT number
- NCT00654953
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 102 participants, actual
- Lead sponsor
- University of Arkansas
- Conditions
- Cocaine Dependence, Depressive Symptoms
- Interventions
- sertraline, Placebo, gabapentin
- First posted
- 2008-04-09
- Last updated
- 2011-04-25
- Results first posted
- 2011-04-25
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites | 70 days | Thrice-weekly urine samples were analyzed for the presence of cocaine/cocaine metabolite. Days to Relapse was defined as time to the second of two urine results consecutively positive for cocaine. |
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 | Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites | 70 days | Participants who completed the two-week residential stay and had 2 urine samples consecutively positive for cocaine were included in the analysis. | Days to relapse (two consec coc+ urines) | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites | Placebo | 19.93 | Standard Deviation 12.16 | Days to relapse (two consec coc+ urines) | |
| Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites | Sertraline | 23.38 | Standard Deviation 17.82 | Days to relapse (two consec coc+ urines) | |
| Urine Toxicology Screens for the Presence of Cocaine/Cocaine Metabolites | Sertraline Plus Gabapentin | 17.27 | Standard Deviation 14.49 | Days to relapse (two consec coc+ urines) |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Group | 36 | |
| Overall Study | STARTED | Active Group: Sertraline Alone | 36 | |
| Overall Study | STARTED | Active Group: Sertraline Plus Gabapentin | 30 | |
| Overall Study | COMPLETED | Placebo Group | 6 | |
| Overall Study | COMPLETED | Active Group: Sertraline Alone | 8 | |
| Overall Study | COMPLETED | Active Group: Sertraline Plus Gabapentin | 8 | |
| Overall Study | NOT COMPLETED | Placebo Group | 30 | |
| Overall Study | NOT COMPLETED | Active Group: Sertraline Alone | 28 | |
| Overall Study | NOT COMPLETED | Active Group: Sertraline Plus Gabapentin | 22 |
Source ClinicalTrials.gov
Adverse events39
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 | sexual dysfunction | Reproductive system and breast disorders | Placebo Group | 1 | 36 | 1 |
| other | sexual dysfunction | Reproductive system and breast disorders | Active Group: Sertraline Alone | 4 | 36 | 4 |
| other | sexual dysfunction | Reproductive system and breast disorders | Active Group: Sertraline Plus Gabapentin | 0 | 30 | 0 |
| other | Chest Pain | Musculoskeletal and connective tissue disorders | Placebo Group | 1 | 36 | 1 |
| other | Chest Pain | Musculoskeletal and connective tissue disorders | Active Group: Sertraline Alone | 2 | 36 | 2 |
| other | Chest Pain | Musculoskeletal and connective tissue disorders | Active Group: Sertraline Plus Gabapentin | 0 | 30 | 0 |
| other | dizziness | Cardiac disorders | Placebo Group | 2 | 36 | 2 |
| other | dizziness | Cardiac disorders | Active Group: Sertraline Alone | 0 | 36 | 0 |
| other | dizziness | Cardiac disorders | Active Group: Sertraline Plus Gabapentin | 1 | 30 | 3 |
| other | headache | Nervous system disorders | Placebo Group | 2 | 36 | 2 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo Group | ||
| Total, all-cause mortality | Active Group: Sertraline Alone | ||
| Total, all-cause mortality | Active Group: Sertraline Plus Gabapentin | ||
| Total, other adverse events | Placebo Group | 7 | 36 |
| Total, other adverse events | Active Group: Sertraline Alone | 17 | 36 |
| Total, other adverse events | Active Group: Sertraline Plus Gabapentin | 14 | 30 |
| Total, serious adverse events | Placebo Group | 0 | 36 |
| Total, serious adverse events | Active Group: Sertraline Alone | 0 | 36 |
| Total, serious adverse events | Active Group: Sertraline Plus Gabapentin | 1 | 30 |
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 |
|---|---|---|---|---|---|
| P50DA018197 | Stimulant Pharmacotherapy: Noradrenergic Targets | KOSTEN, THOMAS RICHARD | BAYLOR COLLEGE OF MEDICINE | NATIONAL INSTITUTE ON DRUG ABUSE | 2004 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/NCT00654953
GET https://conductscience.org/api/trials/v1/NCT00654953/events?page=2