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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

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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

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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.

ListOutcomeTime frameDescription
PrimaryPercent Drinking Days Per Week6 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.
PrimaryPercent Heavy Drinking Days Per Week6 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.
PrimaryTotal Drinks Per Week6 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.
SecondaryPTSD Symptom Assessments6 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.

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPercent Drinking Days Per Week6 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 weekMEAN
PRIMARYPercent Heavy Drinking Days Per Week6 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/weekMEAN
PRIMARYTotal Drinks Per Week6 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 weekMEAN
SECONDARYPTSD Symptom Assessments6 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 scaleMEAN

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Percent Drinking Days Per WeekPrazosin18.195% Confidence Interval -1.1 to 37.4percentage of drinking days per week
Percent Drinking Days Per WeekPlacebo49.395% Confidence Interval 31.7 to 66.9percentage of drinking days per week
Percent Heavy Drinking Days Per WeekPrazosin3.795% Confidence Interval -14.4 to 21.8Percentage of heavy drinking days/week
Percent Heavy Drinking Days Per WeekPlacebo27.495% Confidence Interval 11.3 to 43.5Percentage of heavy drinking days/week
Total Drinks Per WeekPrazosin7.995% Confidence Interval -15.7 to 31.4drinks per week
Total Drinks Per WeekPlacebo2795% Confidence Interval 5.9 to 48.1drinks per week
PTSD Symptom AssessmentsPrazosinTotal PTSD score3.195% Confidence Interval 1.9 to 4.2units on a scale
PTSD Symptom AssessmentsPlaceboTotal PTSD score2.595% Confidence Interval 1.4 to 3.6units on a scale
PTSD Symptom AssessmentsPrazosinRe-experiencing3.295% Confidence Interval 1.9 to 4.4units on a scale
PTSD Symptom AssessmentsPlaceboRe-experiencing2.695% Confidence Interval 1.4 to 3.8units on a scale

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDPrazosin15
Overall StudySTARTEDPlacebo15
Overall StudyCOMPLETEDPrazosin9
Overall StudyCOMPLETEDPlacebo11
Overall StudyNOT COMPLETEDPrazosin6
Overall StudyNOT COMPLETEDPlacebo4

Adverse events6

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherExperienced 1 adverse eventGeneral disordersPlacebo214
otherExperienced 1 adverse eventGeneral disordersPrazosin014
otherExperienced 2 adverse eventsGeneral disordersPlacebo514
otherExperienced 2 adverse eventsGeneral disordersPrazosin114
otherExperienced 3 adverse eventsGeneral disordersPlacebo714
otherExperienced 3 adverse eventsGeneral disordersPrazosin914

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityPlacebo014
Total, all-cause mortalityPrazosin014
Total, other adverse eventsPlacebo1414
Total, other adverse eventsPrazosin1014
Total, serious adverse eventsPlacebo014
Total, serious adverse eventsPrazosin014

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P20AA017839Center for Neuroregulation in Alcohol Dependence (CeNiAD)SAXON, ANDREW JSEATTLE INST FOR BIOMEDICAL/CLINICAL RESNATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM2009 to 2010

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Prazosin vs Placebo: deaths from any causeTrial comparisons
Prazosin vs Placebo: serious adverse eventsTrial 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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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