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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinician Administered PTSD Scale | 12 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). |
| Primary | PTSD 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). |
| Primary | Time 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). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinician Administered PTSD Scale | 12 Weeks | score on a scale | MEAN | |
| PRIMARY | PTSD Checklist (PCL-5) | 12 Weeks | score on a scale | MEAN | |
| PRIMARY | Time Line Follow Back (TLFB) | 12 Weeks | percent | 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 |
|---|---|---|---|---|---|
| Clinician Administered PTSD Scale | Doxazosin | 34.2 | Standard Deviation 9.6 | score on a scale | |
| Clinician Administered PTSD Scale | Placebo | 32.5 | Standard Deviation 8.7 | score on a scale | |
| PTSD Checklist (PCL-5) | Doxazosin | 47.3 | Standard Deviation 14.5 | score on a scale | |
| PTSD Checklist (PCL-5) | Placebo | 46.9 | Standard Deviation 15.2 | score on a scale | |
| Time Line Follow Back (TLFB) | Doxazosin | percentage of days drinking | 53.7 | Standard Deviation 34.8 | percent |
| Time Line Follow Back (TLFB) | Placebo | percentage of days drinking | 48.1 | Standard Deviation 41.2 | percent |
| Time Line Follow Back (TLFB) | Doxazosin | percent heavy days drinking | 37 | Standard Deviation 37.6 | percent |
| Time Line Follow Back (TLFB) | Placebo | percent heavy days drinking | 38.6 | Standard Deviation 38 | percent |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Phase | STARTED | Doxazosin | 74 | |
| Treatment Phase | STARTED | Placebo | 70 | |
| Treatment Phase | COMPLETED | Doxazosin | 68 | |
| Treatment Phase | COMPLETED | Placebo | 69 | |
| Treatment Phase | NOT COMPLETED | Doxazosin | 6 | |
| Treatment Phase | NOT COMPLETED | Placebo | 1 | |
| Follow Up Phase | STARTED | Doxazosin | 68 | |
| Follow Up Phase | STARTED | Placebo | 69 | |
| Follow Up Phase | COMPLETED | Doxazosin | 53 | |
| Follow Up Phase | COMPLETED | Placebo | 47 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events56
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 | Depression | Psychiatric disorders | Doxazosin | 7 | 74 | 7 |
| other | Depression | Psychiatric disorders | Placebo | 5 | 70 | 5 |
| other | Hypotension | Cardiac disorders | Doxazosin | 0 | 74 | 0 |
| other | Hypotension | Cardiac disorders | Placebo | 4 | 70 | 4 |
| other | Hypertension | Cardiac disorders | Doxazosin | 4 | 74 | 4 |
| other | Hypertension | Cardiac disorders | Placebo | 0 | 70 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Doxazosin | 5 | 74 | 5 |
| other | Diarrhea | Gastrointestinal disorders | Placebo | 3 | 70 | 3 |
| other | Stomach Virus/Cramping/Nausea | Gastrointestinal disorders | Doxazosin | 13 | 74 | 13 |
| other | Stomach Virus/Cramping/Nausea | Gastrointestinal disorders | Placebo | 6 | 70 | 6 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Doxazosin | 0 | 74 |
| Total, all-cause mortality | Placebo | 0 | 70 |
| Total, other adverse events | Doxazosin | 48 | 74 |
| Total, other adverse events | Placebo | 40 | 70 |
| Total, serious adverse events | Doxazosin | 12 | 74 |
| Total, serious adverse events | Placebo | 9 | 70 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36883885 | DERIVED |
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.
| Comparison | Source |
|---|---|
| Doxazosin vs Placebo: deaths from any cause | Trial comparisons |
| Doxazosin 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/NCT02500602
GET https://conductscience.org/api/trials/v1/NCT02500602/events?page=2