Trial · NCT00585780
Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
NCT00585780, Phase 1, Phase 2, Completed, Yale University; results first posted 2020-07-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse. Trials, record NCT00585780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00585780
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prazosin to Reduce Stress-Induced Alcohol/Drug Craving and Relapse
- NCT number
- NCT00585780
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Yale University
- Conditions
- Alcohol Dependence
- Interventions
- Prazosin Tablet, Placebo Tablet
- First posted
- 2008-01-03
- Last updated
- 2020-07-27
- Results first posted
- 2020-07-27
- Limitations and caveats
There was not adequate power to assess sex differences, and specific sensitivity and specificity data for apriori AW cutoffs for Prazosin benefit in high AW group needs to be determined in future studies.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Heavy Drinking Days (HDD%) During the Full Dose Period From Weeks 3-12 | daily over 12 weeks | Percentage of heavy drinking days (HDD%) during the full dose period from weeks 3-12 where heavy drinking day (HDD) is defined as 5 or more for men and 4 or more for women in one sitting, measured as yes (1) or no(0), assessed via self reports by daily surveys and time-line follow back assessments |
| Primary | Percent of Drinkings Days During the Full Dose Period Between Weeks 3 and 12 | daily over 12 weeks | Percent of any drinkings days over the full dose period from weeks 3 to 12, defined as any alcoholic drink consumed each day measured as yes (1) or no(0), assessed via self reports by daily surveys and time-line follow back assessments |
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 | Percentage of Heavy Drinking Days (HDD%) During the Full Dose Period From Weeks 3-12 | daily over 12 weeks | Mean percentage of heavy drinking days (HDD%) during the full dose period from weeks 3-12 | percentage of heavy drinking days | MEAN |
| PRIMARY | Percent of Drinkings Days During the Full Dose Period Between Weeks 3 and 12 | daily over 12 weeks | Mean percent of any drinking 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 |
|---|---|---|---|---|---|
| Percentage of Heavy Drinking Days (HDD%) During the Full Dose Period From Weeks 3-12 | High Alcohol Withdrawal (AW) on Prazosin | 8.2 | Standard Error 4.09 | percentage of heavy drinking days | |
| Percentage of Heavy Drinking Days (HDD%) During the Full Dose Period From Weeks 3-12 | High Alcohol Withdrawal (AW) on PLA | 27.11 | Standard Error 7.97 | percentage of heavy drinking days | |
| Percentage of Heavy Drinking Days (HDD%) During the Full Dose Period From Weeks 3-12 | Low Alcohol Withdrawal (AW) on Prazosin | 31.29 | Standard Error 7.42 | percentage of heavy drinking days | |
| Percentage of Heavy Drinking Days (HDD%) During the Full Dose Period From Weeks 3-12 | Low Alcohol Withdrawal (AW) on PLA | 7.32 | Standard Error 3.54 | percentage of heavy drinking days | |
| Percent of Drinkings Days During the Full Dose Period Between Weeks 3 and 12 | High Alcohol Withdrawal on Prazosin | 26.89 | Standard Error 7.45 | Mean percent of any drinking days | |
| Percent of Drinkings Days During the Full Dose Period Between Weeks 3 and 12 | High Alcohol Withdrawal on PLA | 41.21 | Standard Error 9.36 | Mean percent of any drinking days | |
| Percent of Drinkings Days During the Full Dose Period Between Weeks 3 and 12 | Low Alcohol Withdrawal on Prazosin | 53.35 | Standard Error 7.74 | Mean percent of any drinking days | |
| Percent of Drinkings Days During the Full Dose Period Between Weeks 3 and 12 | Low Alcohol Withdrawal on PLA | 23.71 | Standard Error 6.90 | Mean percent of any drinking 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 | High Alcohol Withdrawal on Prazosin | 21 | |
| Overall Study | STARTED | High Alcohol Withdrawal on PLA | 23 | |
| Overall Study | STARTED | Low Alcohol Withdrawal on Prazosin | 34 | |
| Overall Study | STARTED | Low Alcohol Withdrawal on PLA | 22 | |
| Overall Study | COMPLETED | High Alcohol Withdrawal on Prazosin | 13 | |
| Overall Study | COMPLETED | High Alcohol Withdrawal on PLA | 14 | |
| Overall Study | COMPLETED | Low Alcohol Withdrawal on Prazosin | 21 | |
| Overall Study | COMPLETED | Low Alcohol Withdrawal on PLA | 14 | |
| Overall Study | NOT COMPLETED | High Alcohol Withdrawal on Prazosin | 8 | |
| Overall Study | NOT COMPLETED | High Alcohol Withdrawal on PLA | 9 |
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 | Ligtheadedness/dizzy | Cardiac disorders | High Alcohol Withdrawal on Prazosin | 1 | 21 | 2 |
| other | Ligtheadedness/dizzy | Cardiac disorders | High Alcohol Withdrawal on PLA | 1 | 23 | 1 |
| other | Ligtheadedness/dizzy | Cardiac disorders | Low Alcohol Withdrawal on Prazosin | 2 | 34 | 4 |
| other | Ligtheadedness/dizzy | Cardiac disorders | Low Alcohol Withdrawal on PLA | 1 | 22 | 1 |
| other | Pain | Nervous system disorders | High Alcohol Withdrawal on Prazosin | 2 | 21 | 6 |
| other | Pain | Nervous system disorders | High Alcohol Withdrawal on PLA | 1 | 23 | 3 |
| other | Pain | Nervous system disorders | Low Alcohol Withdrawal on Prazosin | 4 | 34 | 4 |
| other | Pain | Nervous system disorders | Low Alcohol Withdrawal on PLA | 2 | 22 | 7 |
| other | Headache | Nervous system disorders | High Alcohol Withdrawal on Prazosin | 1 | 21 | 1 |
| other | Headache | Nervous system disorders | High Alcohol Withdrawal on PLA | 1 | 23 | 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 | High Alcohol Withdrawal on Prazosin | 0 | 21 |
| Total, all-cause mortality | High Alcohol Withdrawal on PLA | 0 | 23 |
| Total, all-cause mortality | Low Alcohol Withdrawal on Prazosin | 0 | 34 |
| Total, all-cause mortality | Low Alcohol Withdrawal on PLA | 0 | 22 |
| Total, other adverse events | High Alcohol Withdrawal on Prazosin | 4 | 21 |
| Total, other adverse events | High Alcohol Withdrawal on PLA | 3 | 23 |
| Total, other adverse events | Low Alcohol Withdrawal on Prazosin | 9 | 34 |
| Total, other adverse events | Low Alcohol Withdrawal on PLA | 2 | 22 |
| Total, serious adverse events | High Alcohol Withdrawal on Prazosin | 0 | 21 |
| Total, serious adverse events | High Alcohol Withdrawal on PLA | 0 | 23 |
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 |
|---|---|---|---|---|---|
| R01AA020504 | Effect of Prazosin on Alcohol Craving, Stress Dysregulation and Alcohol Relapse | SINHA, RAJITA; FOX, HELEN CECILIA | YALE UNIVERSITY | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2012 to 2016 |
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/NCT00585780
GET https://conductscience.org/api/trials/v1/NCT00585780/events?page=2