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Trial · NCT02500602

CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders

NCT02500602, Phase 2, Completed, VA Office of Research and Development; results first posted 2021-04-14

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders. Trials, record NCT02500602. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02500602

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
CAP: Doxazosin in the Treatment of Co-Occurring PTSD and Alcohol Use Disorders
NCT number
NCT02500602
Status
Completed
Phases
Phase 2
Enrollment
144 participants, actual
Lead sponsor
VA Office of Research and Development
Conditions
Posttraumatic Stress Disorder, Alcohol Use Disorders
Interventions
doxazosin, placebo
First posted
2015-07-16
Last updated
2021-05-13
Results first posted
2021-04-14

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryClinician Administered PTSD Scale12 Weeks
The primary PTSD outcome measure was the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5; Weathers et al., 2013). The CAPS-5 is a semi-structured interview that measures the DSM-5 symptoms of PTSD and requires the presence of at least one intrusion symptom, one avoidance symptom, two cognition and mood symptoms, and two arousal symptoms for a period of 1 month or more to reach diagnostic threshold. There are 20 symptom items and responses that are rated on a 5-point scale ranging from 0 (absent) to 4 (extreme/incapacitating), with a total PTSD symptom severity score of the sum of the 20 symptom items ranging from 0-80, and lower scores indicating better outcomes (or less severe PTSD symptomology). The CAPS-5 was assessed at end of treatment (week 12).
PrimaryPTSD Checklist (PCL-5)12 Weeks
The secondary PTSD outcome measure was the PTSD Checklist-5 (PCL-5; Weathers et al., 2013b). The PCL-5 is 20-item self-report measure that assesses the DSM-5 symptoms of PTSD using a severity rating Likert scale ranging from 0 to 4 that indicates the degree of distress across symptoms (0 = not at all to 4 = extremely). The overall score range is 0-80 (and combines the score for all 20 symptoms), with lower scores representing better outcomes (less severe PTSD symptomology). The PCL-5 was assessed at end of treatment (week 12).
PrimaryTime Line Follow Back (TLFB)12 Weeks
The TLFB obtains retrospective self-report of substance use by using a calendar and memory prompts to stimulate recall (Sobell \& Sobell, 1992). Quantity and frequency assessments are made using this instrument (e.g., total number of standard drink units, percent of days using) as well as abstinence (yes/no). TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports (Sobell et al., 2003). The TLFB assesses frequency and amount of substance use over a pre-determined timeframe. TLFB data were collected throughout the trial, and the values reported here represent the TLFB data at end of treatment (week 12).

Outcomes3

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYClinician Administered PTSD Scale12 Weeksscore on a scaleMEAN
PRIMARYPTSD Checklist (PCL-5)12 Weeksscore on a scaleMEAN
PRIMARYTime Line Follow Back (TLFB)12 WeekspercentMEAN

Results by group8

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

OutcomeGroupCategoryValueSpreadUnits
Clinician Administered PTSD ScaleDoxazosin34.2Standard Deviation 9.6score on a scale
Clinician Administered PTSD ScalePlacebo32.5Standard Deviation 8.7score on a scale
PTSD Checklist (PCL-5)Doxazosin47.3Standard Deviation 14.5score on a scale
PTSD Checklist (PCL-5)Placebo46.9Standard Deviation 15.2score on a scale
Time Line Follow Back (TLFB)Doxazosinpercentage of days drinking53.7Standard Deviation 34.8percent
Time Line Follow Back (TLFB)Placebopercentage of days drinking48.1Standard Deviation 41.2percent
Time Line Follow Back (TLFB)Doxazosinpercent heavy days drinking37Standard Deviation 37.6percent
Time Line Follow Back (TLFB)Placebopercent heavy days drinking38.6Standard Deviation 38percent

Participant flow12

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

PeriodMilestoneGroupParticipantsUnits counted
Treatment PhaseSTARTEDDoxazosin74
Treatment PhaseSTARTEDPlacebo70
Treatment PhaseCOMPLETEDDoxazosin68
Treatment PhaseCOMPLETEDPlacebo69
Treatment PhaseNOT COMPLETEDDoxazosin6
Treatment PhaseNOT COMPLETEDPlacebo1
Follow Up PhaseSTARTEDDoxazosin68
Follow Up PhaseSTARTEDPlacebo69
Follow Up PhaseCOMPLETEDDoxazosin53
Follow Up PhaseCOMPLETEDPlacebo47

Adverse events56

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

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDepressionPsychiatric disordersDoxazosin7747
otherDepressionPsychiatric disordersPlacebo5705
otherHypotensionCardiac disordersDoxazosin0740
otherHypotensionCardiac disordersPlacebo4704
otherHypertensionCardiac disordersDoxazosin4744
otherHypertensionCardiac disordersPlacebo0700
otherDiarrheaGastrointestinal disordersDoxazosin5745
otherDiarrheaGastrointestinal disordersPlacebo3703
otherStomach Virus/Cramping/NauseaGastrointestinal disordersDoxazosin137413
otherStomach Virus/Cramping/NauseaGastrointestinal disordersPlacebo6706

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityDoxazosin074
Total, all-cause mortalityPlacebo070
Total, other adverse eventsDoxazosin4874
Total, other adverse eventsPlacebo4070
Total, serious adverse eventsDoxazosin1274
Total, serious adverse eventsPlacebo970

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
36883885DERIVED

Source PubMed

Grants0

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.

None in this release.

Trial comparisons2

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

ComparisonSource
Doxazosin vs Placebo: deaths from any causeTrial comparisons
Doxazosin 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/NCT02500602

GET https://conductscience.org/api/trials/v1/NCT02500602/events?page=2