Trial · NCT00613015
Stress and Medication Effects on Cocaine Cue Reactivity
NCT00613015, Phase 2, Completed, Medical University of South Carolina; results first posted 2013-11-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stress and Medication Effects on Cocaine Cue Reactivity. Trials, record NCT00613015. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00613015
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stress and Medication Effects on Cocaine Cue Reactivity
- NCT number
- NCT00613015
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Cocaine Related Disorders
- Interventions
- Guanfacine, Modafinil, Placebo
- First posted
- 2008-02-12
- Last updated
- 2018-06-04
- Results first posted
- 2013-11-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cocaine Craving | Post Trier social stress task + Cocaine Cue 2:30 pm | Participants were randomized to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to participate in the TRIER social stress task or to read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for 2 minutes and cocaine cues for 2 minutes. Immediately following the cocaine cue exposure, participants were asked to rate cocaine craving on a 10-point Likert scale, with 0 being Not at All and 10 being Extremely. |
| Secondary | Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure | Immediately following trier + cocaine cue exposure | Participants were randomized to receive to the modafinil, guanfacine, or placebo treatment group. Participants were then randomized to complete a TRIER social stress task or read magazines for 15 minutes. Following the task, participants were exposed to neutral cues for two minutes and control cues for two minutes. Immediately following exposure to the cocaine cue, saliva samples were collected to measure cortisol levels. |
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 Craving | Post Trier social stress task + Cocaine Cue 2:30 pm | units on a scale | MEAN | |
| SECONDARY | Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure | Immediately following trier + cocaine cue exposure | mcg/dl | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cocaine Craving | Modafinil/Stress | 3.08 | Standard Deviation 3.59 | units on a scale | |
| Cocaine Craving | Modafinil/No Stress | 4.36 | Standard Deviation 2.84 | units on a scale | |
| Cocaine Craving | Guanfacine/Stress | 1.54 | Standard Deviation 3.06 | units on a scale | |
| Cocaine Craving | Guanfacine/No Stress | 3.13 | Standard Deviation 3.49 | units on a scale | |
| Cocaine Craving | Placebo/Stress | 1.8 | Standard Deviation 2.8 | units on a scale | |
| Cocaine Craving | Placebo/No Stress | 2.11 | Standard Deviation 2.4 | units on a scale | |
| Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure | Modafinil/Stress | 12.55 | Standard Deviation 3.27 | mcg/dl | |
| Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure | Modafinil/No Stress | 11.69 | Standard Deviation 5.57 | mcg/dl | |
| Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure | Guanfacine/Stress | 13.19 | Standard Deviation 5.36 | mcg/dl | |
| Cortisol- 2:30 pm, Immediately Following Trier Social Stress Task + Cocaine Cue Exposure | Guanfacine/No Stress | 9.06 | Standard Deviation 2.19 | mcg/dl |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Modafinil/Stress | 13 | |
| Overall Study | STARTED | Modafinil/No Stress | 12 | |
| Overall Study | STARTED | Guanfacine/Stress | 26 | |
| Overall Study | STARTED | Guanfacine/No Stress | 24 | |
| Overall Study | STARTED | Placebo/Stress | 15 | |
| Overall Study | STARTED | Placebo/No Stress | 19 | |
| Overall Study | COMPLETED | Modafinil/Stress | 13 | |
| Overall Study | COMPLETED | Modafinil/No Stress | 11 | |
| Overall Study | COMPLETED | Guanfacine/Stress | 23 | |
| Overall Study | COMPLETED | Guanfacine/No Stress | 21 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Modafinil/Stress | ||
| Total, all-cause mortality | Modafinil/No Stress | ||
| Total, all-cause mortality | Guanfacine/Stress | ||
| Total, all-cause mortality | Guanfacine/No Stress | ||
| Total, all-cause mortality | Placebo/Stress | ||
| Total, all-cause mortality | Placebo/No Stress | ||
| Total, other adverse events | Modafinil/Stress | 0 | 13 |
| Total, other adverse events | Modafinil/No Stress | 0 | 12 |
| Total, other adverse events | Guanfacine/Stress | 0 | 26 |
| Total, other adverse events | Guanfacine/No Stress | 0 | 24 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 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 |
|---|---|---|---|---|---|
| R01DA021690 | Interdisciplinary Medication Development for Multiple Risk Factors in Relapse | SEE, RONALD E | MEDICAL UNIVERSITY OF SOUTH CAROLINA | NATIONAL INSTITUTE ON DRUG ABUSE | 2007 to 2011 |
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/NCT00613015
GET https://conductscience.org/api/trials/v1/NCT00613015/registered