Trial Outcomes & Findings for Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder (NCT NCT02354703)
NCT ID: NCT02354703
Last Updated: 2022-01-14
Results Overview
self-reported number of standard drinks of alcohol (14 g alcohol) consumed per drinking day
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
293 participants
Primary outcome timeframe
16-week treatment period
Results posted on
2022-01-14
Participant Flow
Participants were enrolled from August, 2015 through December 2019 in the Philadelphia, PA and Baltimore, MD metropolitan areas using print, broadcast, and internet advertising, referral from local clinics, and search of medical records for potential participants.
293 participants were enrolled, which allowed them to be screened for study eligibility. 115 participants meet eligibility criteria and were scheduled for randomization. 6 participants did not remain eligible at baseline visit and 14 participants did not appear at the baseline visit, resulting in 95 participants randomized and starting treatment.
Participant milestones
| Measure |
Ondansetron--non-responsive Genotype
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron-responsive Genotype
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
34
|
39
|
10
|
|
Overall Study
COMPLETED
|
9
|
26
|
28
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
11
|
3
|
Reasons for withdrawal
| Measure |
Ondansetron--non-responsive Genotype
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron-responsive Genotype
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
7
|
9
|
2
|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacogenetic Study of Ondansetron in Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Ondansetron--non-responsive Genotype
n=12 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron-responsive Genotype
n=34 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
n=39 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
n=10 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
54.58 years
STANDARD_DEVIATION 6.96 • n=93 Participants
|
52.29 years
STANDARD_DEVIATION 10.59 • n=4 Participants
|
49.33 years
STANDARD_DEVIATION 12.07 • n=27 Participants
|
53.10 years
STANDARD_DEVIATION 14.04 • n=483 Participants
|
51.5 years
STANDARD_DEVIATION 11.3 • n=36 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=93 Participants
|
26 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
69 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
92 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
35 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
60 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
34 participants
n=4 Participants
|
39 participants
n=27 Participants
|
10 participants
n=483 Participants
|
95 participants
n=36 Participants
|
|
marital status
|
5 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
50 Participants
n=36 Participants
|
|
employment status
|
8 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
74 Participants
n=36 Participants
|
|
education level
|
15.06 years
STANDARD_DEVIATION 2.64 • n=93 Participants
|
15.82 years
STANDARD_DEVIATION 3.79 • n=4 Participants
|
15.33 years
STANDARD_DEVIATION 3.09 • n=27 Participants
|
17.80 years
STANDARD_DEVIATION 1.55 • n=483 Participants
|
15.7 years
STANDARD_DEVIATION 3.2 • n=36 Participants
|
|
lifetime major depressive disorder
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
lifetime anxiety disorder
|
0 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
10 Participants
n=36 Participants
|
|
Beck Depression Inventory (BDI) score
|
4.08 units on a scale
STANDARD_DEVIATION 4.12 • n=93 Participants
|
6.53 units on a scale
STANDARD_DEVIATION 5.81 • n=4 Participants
|
5.22 units on a scale
STANDARD_DEVIATION 5.13 • n=27 Participants
|
2.33 units on a scale
STANDARD_DEVIATION 2.55 • n=483 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 5.2 • n=36 Participants
|
|
Short Index of Problems (SIP)
|
14.33 units on at scale
STANDARD_DEVIATION 11.88 • n=93 Participants
|
14.29 units on at scale
STANDARD_DEVIATION 9.68 • n=4 Participants
|
12.51 units on at scale
STANDARD_DEVIATION 9.13 • n=27 Participants
|
12.30 units on at scale
STANDARD_DEVIATION 6.11 • n=483 Participants
|
13.4 units on at scale
STANDARD_DEVIATION 9.4 • n=36 Participants
|
|
drinks per drinking day (DPDD)
|
5.80 drinks per drinking day
STANDARD_DEVIATION 2.50 • n=93 Participants
|
6.77 drinks per drinking day
STANDARD_DEVIATION 2.90 • n=4 Participants
|
6.32 drinks per drinking day
STANDARD_DEVIATION 2.69 • n=27 Participants
|
6.56 drinks per drinking day
STANDARD_DEVIATION 3.74 • n=483 Participants
|
6.4 drinks per drinking day
STANDARD_DEVIATION 2.8 • n=36 Participants
|
|
percent drinking days (PDD)
|
85.0 percent of days with alcohol drinking
STANDARD_DEVIATION 20.49 • n=93 Participants
|
86.73 percent of days with alcohol drinking
STANDARD_DEVIATION 21.39 • n=4 Participants
|
87.29 percent of days with alcohol drinking
STANDARD_DEVIATION 16.54 • n=27 Participants
|
88.0 percent of days with alcohol drinking
STANDARD_DEVIATION 15.45 • n=483 Participants
|
86.9 percent of days with alcohol drinking
STANDARD_DEVIATION 18.5 • n=36 Participants
|
|
percent heavy drinking days (PHDD)
|
75.92 percent of heavy drinking days
STANDARD_DEVIATION 24.79 • n=93 Participants
|
75.72 percent of heavy drinking days
STANDARD_DEVIATION 26.34 • n=4 Participants
|
70.84 percent of heavy drinking days
STANDARD_DEVIATION 25.7 • n=27 Participants
|
78.56 percent of heavy drinking days
STANDARD_DEVIATION 22.46 • n=483 Participants
|
74.0 percent of heavy drinking days
STANDARD_DEVIATION 18.3 • n=36 Participants
|
PRIMARY outcome
Timeframe: 16-week treatment periodself-reported number of standard drinks of alcohol (14 g alcohol) consumed per drinking day
Outcome measures
| Measure |
Ondansetron-responsive Genotype
n=34 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron--non-responsive Genotype
n=12 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
n=39 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
n=10 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
|---|---|---|---|---|
|
Drinks Per Drinking Day
|
3.70 drinks per drinking day
Standard Deviation 2.44
|
3.60 drinks per drinking day
Standard Deviation 2.20
|
3.37 drinks per drinking day
Standard Deviation 2.35
|
3.99 drinks per drinking day
Standard Deviation 3.81
|
SECONDARY outcome
Timeframe: 16-week treatment periodself-reported percentage of days on which the participant drank alcohol
Outcome measures
| Measure |
Ondansetron-responsive Genotype
n=12 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron--non-responsive Genotype
n=34 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
n=39 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
n=10 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
|---|---|---|---|---|
|
Percent Drinking Days
|
71.92 percentage of drinking days
Standard Deviation 15.08
|
67.51 percentage of drinking days
Standard Deviation 26.33
|
68.00 percentage of drinking days
Standard Deviation 27.09
|
66.84 percentage of drinking days
Standard Deviation 34.39
|
SECONDARY outcome
Timeframe: 16-week treatment periodself-reported percentage of days with heavy drinking (at least 5 drinks/day for men, at least 4 drinks/day for women)
Outcome measures
| Measure |
Ondansetron-responsive Genotype
n=12 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron--non-responsive Genotype
n=34 Participants
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
n=39 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
n=10 Participants
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
|---|---|---|---|---|
|
Percent Heavy Drinking Days
|
32.93 percentage of days with heavy drinking
Standard Deviation 23.59
|
40.49 percentage of days with heavy drinking
Standard Deviation 32.08
|
31.96 percentage of days with heavy drinking
Standard Deviation 27.27
|
35.13 percentage of days with heavy drinking
Standard Deviation 35.04
|
Adverse Events
Ondansetron--non-responsive Genotype
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Ondansetron-responsive Genotype
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo--responsive Genotype
Serious events: 1 serious events
Other events: 34 other events
Deaths: 0 deaths
Placebo--non-responsive Genotype
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ondansetron--non-responsive Genotype
n=12 participants at risk
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron-responsive Genotype
n=34 participants at risk
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
n=39 participants at risk
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
n=10 participants at risk
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
|---|---|---|---|---|
|
Cardiac disorders
atrial fibrillation
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
2.6%
1/39 • Number of events 1 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
Other adverse events
| Measure |
Ondansetron--non-responsive Genotype
n=12 participants at risk
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Ondansetron-responsive Genotype
n=34 participants at risk
ondansetron-0.33 mg bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Ondansetron: Ondansetron (0.33 mg) bid+ BBCET counseling
|
Placebo--responsive Genotype
n=39 participants at risk
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and carrying one of the following genotypes:
if European ancestry:
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
HTR3A gene:
rs1150226:AG; or rs1176713:GG
HTR3B gene:
rs17619942:AC
If African ancestry:
HTR3B gene:
rs176744: CC or CA
SLC6A4 gene:
5-HTTLPR:LL, or rs25531:AA, or 5-HTTLPR + rs25531 (LALA genotype) or rs1042173:TT
Placebo: Placebo + BBCET counseling
|
Placebo--non-responsive Genotype
n=10 participants at risk
placebo bid + Brief Behavioral Compliance Enhancement Treatment (BBCET) for 16 weeks and NOT carrying any of the responsive genotypes
Placebo: Placebo + BBCET counseling
|
|---|---|---|---|---|
|
Nervous system disorders
nervous system
|
25.0%
3/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
35.3%
12/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
33.3%
13/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
30.0%
3/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Gastrointestinal disorders
gastrointestinal
|
25.0%
3/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
29.4%
10/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
30.8%
12/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
20.0%
2/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Infections and infestations
infections
|
41.7%
5/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
50.0%
7/14 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
30.8%
12/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
30.0%
3/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal & connective tissue
|
33.3%
4/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
17.6%
6/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
17.9%
7/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
40.0%
4/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Skin and subcutaneous tissue disorders
skin & subcutaneous tissue
|
16.7%
2/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
5.9%
2/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
33.3%
13/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.0%
1/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Psychiatric disorders
psychiatric
|
8.3%
1/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
23.5%
8/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.3%
4/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
30.0%
3/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
General disorders
general disorders
|
16.7%
2/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
14.7%
5/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.3%
4/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
30.0%
3/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Injury, poisoning and procedural complications
injury, poisoning, procedural
|
16.7%
2/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
5.9%
2/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.3%
4/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.0%
1/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory
|
8.3%
1/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
5.9%
2/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
5.1%
2/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.0%
1/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Immune system disorders
immune
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
11.8%
4/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
2.6%
1/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Eye disorders
eye
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
7.7%
3/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.0%
1/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Blood and lymphatic system disorders
blood & lymphatic
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
5.9%
2/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
2.6%
1/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Metabolism and nutrition disorders
metabolism & nutrition
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
5.9%
2/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
2.6%
1/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Reproductive system and breast disorders
reproductive & breast
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
2.6%
1/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.0%
1/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Ear and labyrinth disorders
ear
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
5.9%
2/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
|
Renal and urinary disorders
renal & urinary
|
0.00%
0/12 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/34 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
0.00%
0/39 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
10.0%
1/10 • 16-week treatment period
Adverse events assessed by participant self-report. Many events were assessed without regard to a specific Adverse Event Term.
|
Additional Information
Dr. David Gorelick
University of Maryland School of Medicine
Phone: 410-408-6806
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place