Trial · NCT02884908
Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD
NCT02884908, Phase 3, Completed, University of Maryland, Baltimore; results first posted 2024-03-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD. Trials, record NCT02884908. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02884908
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD
- NCT number
- NCT02884908
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- University of Maryland, Baltimore
- Conditions
- PTSD, Alcohol Use Disorder
- Interventions
- Pregabalin plus BBCET, Placebo plus BBCET
- First posted
- 2016-08-31
- Last updated
- 2024-03-13
- Results first posted
- 2024-03-13
- Limitations and caveats
Sample size calculated for effect size=0.31, attrition=25%, correlation among repeated measures=0.55. With power=0.80 \& alpha-level=.05/2=.025, N=198 randomized. Due to interruptions/pandemic, N=57 randomized; final analysis N=44 (26 pregabalin/18 placebo). Re-calculated power based on modified primary analysis, achieved sample size, observed attrition rates (40%), \& average correlation among repeated measures. Aim1 effect size=0.67, 2-sided alpha=0.05, power=0.80. Aim2 effect sizes=0.68 \& 0.63.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) | 12 weeks | Heavy drinking days will be derived from the data collected by the TLFB interview for the last 7 days. |
| Primary | PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) | 12 weeks | PTSD Cluster B symptoms assessed during treatment will be derived from the data collected with the PCL. |
| Primary | PTSD Cluster E Symptoms as Measured by the PCL | 12 weeks | PTSD Cluster E symptoms assessed during treatment will be derived from the data collected with the PCL. |
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 | Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) | 12 weeks | 44 took at least 1 dose of study medication: 26 in the experimental condition and 18 in the placebo condition. This is the analysis population. For some outcomes, there was missing data at the 12-week assessment. | days | MEAN |
| PRIMARY | PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) | 12 weeks | 4 took at least 1 dose of study medication: 26 in the experimental condition and 18 in the placebo condition. This is the analysis population. For some outcomes, there was missing data at the 12-week assessment. | number of symptoms | MEAN |
| PRIMARY | PTSD Cluster E Symptoms as Measured by the PCL | 12 weeks | 44 took at least 1 dose of study medication: 26 in the experimental condition and 18 in the placebo condition. This is the analysis population. For some outcomes, there was missing data at the 12-week assessment. | number of symptoms | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) | Pregabalin + BBCET | Baseline | 10.5 | Standard Deviation 13.1 | days |
| Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) | Placebo + BBCET | Baseline | 10.2 | Standard Deviation 11.2 | days |
| Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) | Pregabalin + BBCET | 12-week assessment | 1.1 | Standard Deviation 2.0 | days |
| Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) | Placebo + BBCET | 12-week assessment | 1.0 | Standard Deviation 1.8 | days |
| PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) | Pregabalin + BBCET | Baseline | 9.7 | Standard Deviation 4.7 | number of symptoms |
| PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) | Placebo + BBCET | Baseline | 9.8 | Standard Deviation 4.1 | number of symptoms |
| PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) | Pregabalin + BBCET | 12-week assessment | 3.6 | Standard Deviation 4.6 | number of symptoms |
| PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) | Placebo + BBCET | 12-week assessment | 1.6 | Standard Deviation 2.2 | number of symptoms |
| PTSD Cluster E Symptoms as Measured by the PCL | Pregabalin + BBCET | Baseline | 12.2 | Standard Deviation 5.4 | number of symptoms |
| PTSD Cluster E Symptoms as Measured by the PCL | Placebo + BBCET | Baseline | 13.3 | Standard Deviation 4.8 | number of symptoms |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pregabalin + BBCET | 32 | |
| Overall Study | STARTED | Placebo + BBCET | 25 | |
| Overall Study | African American | Pregabalin + BBCET | 30 | |
| Overall Study | African American | Placebo + BBCET | 24 | |
| Overall Study | Took 1 Dose of Study Medication | Pregabalin + BBCET | 26 | |
| Overall Study | Took 1 Dose of Study Medication | Placebo + BBCET | 18 | |
| Overall Study | COMPLETED | Pregabalin + BBCET | 19 | |
| Overall Study | COMPLETED | Placebo + BBCET | 7 | |
| Overall Study | NOT COMPLETED | Pregabalin + BBCET | 13 | |
| Overall Study | NOT COMPLETED | Placebo + BBCET | 18 |
Source ClinicalTrials.gov
Adverse events26
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 | Reports of medical or psychiatric issues | Ear and labyrinth disorders | Pregabalin + BBCET | 4 | 26 | |
| other | Reports of medical or psychiatric issues | Ear and labyrinth disorders | Placebo + BBCET | 1 | 18 | |
| other | Reports of medical or psychiatric issues | Blood and lymphatic system disorders | Pregabalin + BBCET | 1 | 26 | |
| other | Reports of medical or psychiatric issues | Blood and lymphatic system disorders | Placebo + BBCET | 0 | 18 | |
| other | Reports of medical or psychiatric issues | Eye disorders | Pregabalin + BBCET | 2 | 26 | |
| other | Reports of medical or psychiatric issues | Eye disorders | Placebo + BBCET | 0 | 18 | |
| other | Reports of medical or psychiatric issues | Gastrointestinal disorders | Pregabalin + BBCET | 7 | 26 | |
| other | Reports of medical or psychiatric issues | Gastrointestinal disorders | Placebo + BBCET | 3 | 18 | |
| other | Reports of medical or psychiatric issues | General disorders | Pregabalin + BBCET | 12 | 26 | |
| other | Reports of medical or psychiatric issues | General disorders | Placebo + BBCET | 10 | 18 |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pregabalin + BBCET | 0 | 26 |
| Total, all-cause mortality | Placebo + BBCET | 0 | 18 |
| Total, other adverse events | Pregabalin + BBCET | 26 | 26 |
| Total, other adverse events | Placebo + BBCET | 18 | 18 |
| Total, serious adverse events | Pregabalin + BBCET | 1 | 26 |
| Total, serious adverse events | Placebo + BBCET | 1 | 18 |
Source ClinicalTrials.gov
Papers17
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| R01AA024760 | Pharmacogenetic Treatment with Anti-Glutaminergic Agents for Comorbid PTSD & AUD | BENNETT, MELANIE E. | UNIVERSITY OF MARYLAND BALTIMORE | NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM | 2016 to 2020 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Pregabalin + BBCET vs Placebo + BBCET: deaths from any cause | Trial comparisons |
| Pregabalin + BBCET vs Placebo + BBCET: 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/NCT02884908
GET https://conductscience.org/api/trials/v1/NCT02884908/events?page=2