Trial Outcomes & Findings for Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD (NCT NCT02884908)

NCT ID: NCT02884908

Last Updated: 2024-03-13

Results Overview

Heavy drinking days will be derived from the data collected by the TLFB interview for the last 7 days.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

57 participants

Primary outcome timeframe

12 weeks

Results posted on

2024-03-13

Participant Flow

The trial took place at University of Maryland School of Medicine. Participants were from Baltimore and surrounding counties. The study ran 7/17-6/19 when the research center closed. Recruitment resumed 7/19-3/20 when it stopped due to the pandemic. Recruitment resumed 10/20-12/21 with a 1-month stoppage in 1/21 due to the pandemic.

N=152 signed consent. Of these, 57 were randomized: 32 to pregabalin, 25 to placebo. 94 were not randomized: 1) did not meet alcohol use disorder criteria; 2) did not meet criteria for PTSD or other trauma disorder; 3) did not meet other eligibility criteria.

Participant milestones

Participant milestones
Measure	Pregabalin + BBCET This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
Overall Study STARTED	32	25
Overall Study African American	30	24
Overall Study Took 1 Dose of Study Medication	26	18
Overall Study COMPLETED	19	7
Overall Study NOT COMPLETED	13	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin + BBCET This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
Overall Study Lost to Follow-up	13	18

Baseline Characteristics

Pharmacogenetic Treatment With Anti-Glutaminergic Agents for Comorbid PTSD & AUD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin + BBCET n=32 Participants This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET n=25 Participants This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment	Total n=57 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 11.0 • n=5 Participants	42.5 years STANDARD_DEVIATION 13.0 • n=7 Participants	43.4 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	32 Participants n=5 Participants	24 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Diagnostic and Statistical Manual 5 (DSM5) Alcohol Use Disorder (AUD) severity	7.8 Number of AUD symptoms STANDARD_DEVIATION 2.3 • n=5 Participants	8.3 Number of AUD symptoms STANDARD_DEVIATION 1.7 • n=7 Participants	8.0 Number of AUD symptoms STANDARD_DEVIATION 2.1 • n=5 Participants
Heavy drinking days in the last 30 days	10.3 days STANDARD_DEVIATION 13.2 • n=5 Participants	9.9 days STANDARD_DEVIATION 11.4 • n=7 Participants	10.2 days STANDARD_DEVIATION 12.4 • n=5 Participants
PTSD Cluster B Symptoms (last week)	9.5 Number of symptoms STANDARD_DEVIATION 4.7 • n=5 Participants	9.8 Number of symptoms STANDARD_DEVIATION 4.2 • n=7 Participants	9.7 Number of symptoms STANDARD_DEVIATION 4.5 • n=5 Participants
PTSD Cluster E Symptoms (last week)	11.5 Number of symptoms STANDARD_DEVIATION 5.6 • n=5 Participants	13.1 Number of symptoms STANDARD_DEVIATION 4.3 • n=7 Participants	12.2 Number of symptoms STANDARD_DEVIATION 5.1 • n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

Heavy drinking days will be derived from the data collected by the TLFB interview for the last 7 days.

Outcome measures

Outcome measures
Measure	Pregabalin + BBCET n=26 Participants This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET n=18 Participants This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) Baseline	10.5 days Standard Deviation 13.1	10.2 days Standard Deviation 11.2
Heavy Drinking Days as Measured by the Time Line Follow Back (TLFB) 12-week assessment	1.1 days Standard Deviation 2.0	1.0 days Standard Deviation 1.8

PRIMARY outcome

Timeframe: 12 weeks

Population: 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.

PTSD Cluster B symptoms assessed during treatment will be derived from the data collected with the PCL.

Outcome measures

Outcome measures
Measure	Pregabalin + BBCET n=26 Participants This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET n=18 Participants This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) Baseline	9.7 number of symptoms Standard Deviation 4.7	9.8 number of symptoms Standard Deviation 4.1
PTSD Cluster B Symptoms as Measured by the PTSD Checklist (PCL) 12-week assessment	3.6 number of symptoms Standard Deviation 4.6	1.6 number of symptoms Standard Deviation 2.2

PRIMARY outcome

Timeframe: 12 weeks

PTSD Cluster E symptoms assessed during treatment will be derived from the data collected with the PCL.

Outcome measures

Outcome measures
Measure	Pregabalin + BBCET n=26 Participants This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET n=18 Participants This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
PTSD Cluster E Symptoms as Measured by the PCL Baseline	12.2 number of symptoms Standard Deviation 5.4	13.3 number of symptoms Standard Deviation 4.8
PTSD Cluster E Symptoms as Measured by the PCL 12-week assessment	6.4 number of symptoms Standard Deviation 5.0	4.4 number of symptoms Standard Deviation 3.9

Adverse Events

Pregabalin + BBCET

Serious events: 1 serious events

Other events: 26 other events

Deaths: 0 deaths

Placebo + BBCET

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Pregabalin + BBCET n=26 participants at risk This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET n=18 participants at risk This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
General disorders Hospitalization	3.8% 1/26 • Number of events 1 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	5.6% 1/18 • Number of events 1 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.

Other adverse events

Other adverse events
Measure	Pregabalin + BBCET n=26 participants at risk This group will be comprised of subjects with the NI/I/II type who receive study medication (Pregabalin) and Brief Behavioral Compliance Enhancement Treatment (BBCET). Pregabalin plus BBCET: Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment	Placebo + BBCET n=18 participants at risk This group will be comprised of subjects with the NI/I/II type who receive placebo and Brief Behavioral Compliance Enhancement Treatment (BBCET). Placebo plus BBCET: Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
Ear and labyrinth disorders Reports of medical or psychiatric issues	15.4% 4/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	5.6% 1/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Blood and lymphatic system disorders Reports of medical or psychiatric issues	3.8% 1/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	0.00% 0/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Eye disorders Reports of medical or psychiatric issues	7.7% 2/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	0.00% 0/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Gastrointestinal disorders Reports of medical or psychiatric issues	26.9% 7/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	16.7% 3/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
General disorders Reports of medical or psychiatric issues	46.2% 12/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	55.6% 10/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Infections and infestations Reports of medical or psychiatric issues	11.5% 3/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	11.1% 2/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Metabolism and nutrition disorders Reports of medical or psychiatric issues	11.5% 3/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	11.1% 2/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Nervous system disorders Reports of medical or psychiatric issues	15.4% 4/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	11.1% 2/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Psychiatric disorders Reports of medical or psychiatric issues	15.4% 4/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	5.6% 1/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Renal and urinary disorders Reports of medical or psychiatric issues	3.8% 1/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	11.1% 2/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Respiratory, thoracic and mediastinal disorders Reports of medical or psychiatric issues	7.7% 2/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	0.00% 0/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.
Skin and subcutaneous tissue disorders Reports of medical or psychiatric issues	11.5% 3/26 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.	5.6% 1/18 • 14 weeks SAEs \& AEs were assessed at each visit. SAEs required review/determination by study physician. AE determinations made by study staff. SAEs were medical or psychiatric hospitalizations of any duration. AEs were any reports of medical or psychiatric issues made by participants when queried about their health status in the last week or since the last study visit that did not require hospitalization. Adverse Events were monitored/assessed without regard to specific Adverse Event Term.

Additional Information

Dr. Melanie Bennett

University of Maryland School of Medicine

Phone: 4107060892

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place