Trial · NCT01518972
Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder
NCT01518972, Phase 2, Completed, Seattle Institute for Biomedical and Clinical Research; results first posted 2020-08-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder. Trials, record NCT01518972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01518972
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder
- NCT number
- NCT01518972
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 30 participants, actual
- Lead sponsor
- Seattle Institute for Biomedical and Clinical Research
- Conditions
- Alcohol Abuse, Posttraumatic Stress Disorder
- Interventions
- Prazosin, Placebo medication
- First posted
- 2012-01-26
- Last updated
- 2020-08-25
- Results first posted
- 2020-08-25
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Drinking Days Per Week | 6 weeks | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The percentage of drinking days of each participant was calculated by summing the number of drinking days and comparing them with the number of total drinking days in the same week. The percentage of drinking days from each week was added and averaged to get the percentage of drinking days per week per participant. The percentage of drinking days of all participants in the Prazosin group was added and averaged to get the mean of the percentage of weekly drinking days of the Prazosin group. These steps were repeated for the Placebo group. |
| Primary | Percent Heavy Drinking Days Per Week | 6 weeks | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. Heavy drinking was defined as 5 or more drinks per day for men and 4 or more drinks per day for women. The percentage of heavy drinking days of each participant was calculated by summing the number of heavy drinking days and comparing them with the total number of drinking days in the same week. The percentage of heavy drinking days from each week was added and averaged to get the percentage of heavy drinking days per week per participant. The percentage of heavy drinking days of all participants in the Prazosin group was added and averaged to get the mean of percentage of weekly heavy drinking days of the Prazosin group. These steps were repeated for the Placebo group. |
| Primary | Total Drinks Per Week | 6 weeks | Data for this measure came from the Form-42 and daily IVR (Interactive Voice Response) monitoring. The weekly total drinks of each participant were calculated by adding the number of drinks by week. The total drinks from each week were added and averaged to get the weekly total drinks of each participant. The weekly total drinks of all participants in the Prazosin group were added and averaged to get the total drinks per week for the Prazosin group. These steps were repeated for the Placebo group. |
| Secondary | PTSD Symptom Assessments | 6 weeks | PTSD symptoms/changes in PTSD (Post-Traumatic Stress Disorder) symptomatology was calculated using data from the IVR (interactive Voice Response) monitoring. PTSD scores were derived by computing the daily average of the item totals for overall PTSD and the symptom clusters. The rating range was 0 (not at all) to 8 (extremely). The higher the score/rating, the more severe the PTSD symptoms. The lowest and highest possible average are 0 and 8, respectively. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Drinking Days Per Week | 6 weeks | Percent drinking days per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, \& treatment group x time interaction. Time was modeled as a categorical variable. | percentage of drinking days per week | MEAN |
| PRIMARY | Percent Heavy Drinking Days Per Week | 6 weeks | Percent heavy drinking days per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, \& treatment group x time interaction. Time was modeled as a categorical variable. | Percentage of heavy drinking days/week | MEAN |
| PRIMARY | Total Drinks Per Week | 6 weeks | The total number of drinks per week was examined using multilevel mixed-effects linear regression models with random slope that included treatment group, time, \& treatment group x time interaction. Time was modeled as a categorical variable. | drinks per week | MEAN |
| SECONDARY | PTSD Symptom Assessments | 6 weeks | PTSD outcomes between weeks 1 and 6 were analyzed using multilevel mixed-effects linear regression models. Models were adjusted for baseline PTSD severity as measured by corresponding PSS-I scores \& sub-scores because measures comparable to the IVR PTSD measures were not available at baseline. Analyses were also adjusted for gender. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Drinking Days Per Week | Prazosin | 18.1 | 95% Confidence Interval -1.1 to 37.4 | percentage of drinking days per week | |
| Percent Drinking Days Per Week | Placebo | 49.3 | 95% Confidence Interval 31.7 to 66.9 | percentage of drinking days per week | |
| Percent Heavy Drinking Days Per Week | Prazosin | 3.7 | 95% Confidence Interval -14.4 to 21.8 | Percentage of heavy drinking days/week | |
| Percent Heavy Drinking Days Per Week | Placebo | 27.4 | 95% Confidence Interval 11.3 to 43.5 | Percentage of heavy drinking days/week | |
| Total Drinks Per Week | Prazosin | 7.9 | 95% Confidence Interval -15.7 to 31.4 | drinks per week | |
| Total Drinks Per Week | Placebo | 27 | 95% Confidence Interval 5.9 to 48.1 | drinks per week | |
| PTSD Symptom Assessments | Prazosin | Total PTSD score | 3.1 | 95% Confidence Interval 1.9 to 4.2 | units on a scale |
| PTSD Symptom Assessments | Placebo | Total PTSD score | 2.5 | 95% Confidence Interval 1.4 to 3.6 | units on a scale |
| PTSD Symptom Assessments | Prazosin | Re-experiencing | 3.2 | 95% Confidence Interval 1.9 to 4.4 | units on a scale |
| PTSD Symptom Assessments | Placebo | Re-experiencing | 2.6 | 95% Confidence Interval 1.4 to 3.8 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Prazosin | 15 | |
| Overall Study | STARTED | Placebo | 15 | |
| Overall Study | COMPLETED | Prazosin | 9 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Prazosin | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events6
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 | Experienced 1 adverse event | General disorders | Placebo | 2 | 14 | |
| other | Experienced 1 adverse event | General disorders | Prazosin | 0 | 14 | |
| other | Experienced 2 adverse events | General disorders | Placebo | 5 | 14 | |
| other | Experienced 2 adverse events | General disorders | Prazosin | 1 | 14 | |
| other | Experienced 3 adverse events | General disorders | Placebo | 7 | 14 | |
| other | Experienced 3 adverse events | General disorders | Prazosin | 9 | 14 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 14 |
| Total, all-cause mortality | Prazosin | 0 | 14 |
| Total, other adverse events | Placebo | 14 | 14 |
| Total, other adverse events | Prazosin | 10 | 14 |
| Total, serious adverse events | Placebo | 0 | 14 |
| Total, serious adverse events | Prazosin | 0 | 14 |
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 |
|---|---|---|---|---|---|
| P20AA017839 | Center for Neuroregulation in Alcohol Dependence (CeNiAD) | SAXON, ANDREW J | SEATTLE INST FOR BIOMEDICAL/CLINICAL RES | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2009 to 2010 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prazosin vs Placebo: deaths from any cause | Trial comparisons |
| Prazosin 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/NCT01518972
GET https://conductscience.org/api/trials/v1/NCT01518972/registered