Trial Outcomes & Findings for Ketamine/Placebo Family History Positive Study (NCT NCT00588952)

NCT ID: NCT00588952

Last Updated: 2021-10-06

Results Overview

Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 99 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-10-06

Participant Flow

Participant milestones

Measure	Family History Positive Subjects with a positive family history of alcoholism Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes	Family History Negative Subjects with a negative family history of alcoholism Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes
Overall Study STARTED	29	70
Overall Study COMPLETED	26	63
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Measure	Family History Positive Subjects with a positive family history of alcoholism Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes	Family History Negative Subjects with a negative family history of alcoholism Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes
Overall Study Adverse Event	0	2
Overall Study Withdrawal by Subject	3	5

Baseline Characteristics

Ketamine/Placebo Family History Positive Study

Baseline characteristics by cohort

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine and Placebo: Two test days will involve administration of placebo and Ketamine (0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute) intravenously for 60 minutes	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	70 Participants n=7 Participants	99 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	24.97 years STANDARD_DEVIATION 3.02 • n=5 Participants	24.13 years STANDARD_DEVIATION 2.34 • n=7 Participants	24.37 years STANDARD_DEVIATION 2.57 • n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	36 Participants n=7 Participants	49 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	34 Participants n=7 Participants	50 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	70 participants n=7 Participants	99 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Ketamine	0.63 units on a scale Standard Deviation 1.15	0.96 units on a scale Standard Deviation 2.14
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Placebo	0.71 units on a scale Standard Deviation 2.18	1.25 units on a scale Standard Deviation 2.46

PRIMARY outcome

Timeframe: 15 minutes

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Ketamine	18.96 units on a scale Standard Deviation 14.92	24.74 units on a scale Standard Deviation 17.34
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Placebo	2.46 units on a scale Standard Deviation 7.12	1.36 units on a scale Standard Deviation 2.89

PRIMARY outcome

Timeframe: 45 minutes

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Ketamine	18.36 units on a scale Standard Deviation 12.49	25.06 units on a scale Standard Deviation 18.22
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Placebo	1.46 units on a scale Standard Deviation 4.34	1.64 units on a scale Standard Deviation 4.03

PRIMARY outcome

Timeframe: 80 minutes

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the sedative effects (0 not at all sedated - 70 extremely sedated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Ketamine	7.46 units on a scale Standard Deviation 12.16	9.99 units on a scale Standard Deviation 13.04
Biphasic Alcohol Effects Scale (BAES) - Subscale Sedation Placebo	1.07 units on a scale Standard Deviation 3.16	0.92 units on a scale Standard Deviation 2.03

PRIMARY outcome

Timeframe: Baseline

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Ketamine	3.78 units on a scale Standard Deviation 8.66	2.43 units on a scale Standard Deviation 7.25
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Placebo	2.36 units on a scale Standard Deviation 6.14	2.88 units on a scale Standard Deviation 7.57

PRIMARY outcome

Timeframe: 15 minutes

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Ketamine	22.39 units on a scale Standard Deviation 22.53	14.58 units on a scale Standard Deviation 15.72
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Placebo	1.82 units on a scale Standard Deviation 4.10	1.82 units on a scale Standard Deviation 5.5

PRIMARY outcome

Timeframe: 45 minutes

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Ketamine	15.4 units on a scale Standard Deviation 19.09	9.06 units on a scale Standard Deviation 12.69
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Placebo	1.54 units on a scale Standard Deviation 3.50	1.64 units on a scale Standard Deviation 5.29

PRIMARY outcome

Timeframe: 80 minutes

Population: All available data was utilized in the analysis using mixed models

Self-reporting rating scale to measure the stimulation effects (0 not at all stimulated - 70 extremely stimulated) of alcohol effects. We used the BAES to measure alcohol-like effects in subjects that received ketamine infusions.

Outcome measures

Measure	Family History Positive n=29 Participants Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 Participants Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Ketamine	3.81 units on a scale Standard Deviation 8.45	3.02 units on a scale Standard Deviation 8.12
Biphasic Alcohol Effects Scale (BAES) - Subscale Stimulation Placebo	1.61 units on a scale Standard Deviation 3.66	2.12 units on a scale Standard Deviation 6.42

Adverse Events

Family History Positive

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Family History Negative

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Family History Positive n=29 participants at risk Subjects with a positive family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution	Family History Negative n=70 participants at risk Subjects with a negative family history of alcoholism Ketamine: Ketamine: 0.23 mg/kg, loading dose and infusion rate 0.58 mg/kg/minute for 60 minutes, IV Placebo: Placebo: loading dose and an infusion for 60 minutes saline solution
Psychiatric disorders Anxiety	0.00% 0/29	1.4% 1/70 • Number of events 1
Gastrointestinal disorders Vomiting	0.00% 0/29	1.4% 1/70 • Number of events 1

Additional Information

Ismene Petrakis

Yale University

Phone: 203-932-5711

Email: Ismene.petrakis@yale.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place