Trial Outcomes & Findings for Development of Ivermectin for Alcohol Use Disorders (NCT NCT02046200)
NCT ID: NCT02046200
Last Updated: 2018-08-08
Results Overview
Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl
Results posted on
2018-08-08
Participant Flow
Participant milestones
| Measure |
IVM 30mg First, Then Placebo
First Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Second Intervention, Placebo: Single dose sugar pill, matched to active medication.
|
Placebo First, Then IVM 30 mg
First Intervention, Placebo: Single dose sugar pill, matched to active medication.
Second Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
|---|---|---|
|
First Intervention (1 Day)
STARTED
|
5
|
6
|
|
First Intervention (1 Day)
COMPLETED
|
5
|
6
|
|
First Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (1 Day)
STARTED
|
5
|
6
|
|
Second Intervention (1 Day)
COMPLETED
|
5
|
6
|
|
Second Intervention (1 Day)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Development of Ivermectin for Alcohol Use Disorders
Baseline characteristics by cohort
| Measure |
IVM 30mg; Placebo
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Placebo: Single dose sugar pill matched to active medication.
|
|---|---|
|
Age, Continuous
|
38.82 years
STANDARD_DEVIATION 11.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Meets criteria for DSM-V AD
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dlPopulation: All randomized subjects included.
Heart rate (measured in beats per minute; BPM) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). During the infusion, the times for collecting HR will vary based on how long it takes participants to reach the targeted BrACs.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Heart Rate
16 hours post-med
|
61.18 BPM
Standard Deviation 12.08
|
58.09 BPM
Standard Deviation 10.97
|
—
|
—
|
—
|
—
|
|
Heart Rate
0 hours post-med
|
64.57 BPM
Standard Deviation 9.74
|
68.36 BPM
Standard Deviation 20.47
|
—
|
—
|
—
|
—
|
|
Heart Rate
0.5 hours post-med
|
66.82 BPM
Standard Deviation 10.91
|
62.82 BPM
Standard Deviation 11.46
|
—
|
—
|
—
|
—
|
|
Heart Rate
1 hour post-med
|
66.09 BPM
Standard Deviation 12.01
|
64.27 BPM
Standard Deviation 11.60
|
—
|
—
|
—
|
—
|
|
Heart Rate
2 hours post-med
|
65.18 BPM
Standard Deviation 13.88
|
61.18 BPM
Standard Deviation 11.03
|
—
|
—
|
—
|
—
|
|
Heart Rate
4 hours post-med
|
66.73 BPM
Standard Deviation 10.60
|
61.55 BPM
Standard Deviation 12.36
|
—
|
—
|
—
|
—
|
|
Heart Rate
6 hours post-med
|
63.27 BPM
Standard Deviation 12.66
|
59.73 BPM
Standard Deviation 12.62
|
—
|
—
|
—
|
—
|
|
Heart Rate
8 hours post-med
|
66.36 BPM
Standard Deviation 13.44
|
62.18 BPM
Standard Deviation 11.76
|
—
|
—
|
—
|
—
|
|
Heart Rate
10 hours post-med
|
64.70 BPM
Standard Deviation 14.33
|
62.64 BPM
Standard Deviation 10.19
|
—
|
—
|
—
|
—
|
|
Heart Rate
12 hours post-med
|
72.45 BPM
Standard Deviation 13.41
|
73.64 BPM
Standard Deviation 9.31
|
—
|
—
|
—
|
—
|
|
Heart Rate
24 hours post-med
|
62.55 BPM
Standard Deviation 11.09
|
64.64 BPM
Standard Deviation 10.58
|
—
|
—
|
—
|
—
|
|
Heart Rate
48 hours post-med
|
69.18 BPM
Standard Deviation 10.15
|
69.45 BPM
Standard Deviation 12.49
|
—
|
—
|
—
|
—
|
|
Heart Rate
BrAC = 0
|
63.09 BPM
Standard Deviation 12.69
|
61.00 BPM
Standard Deviation 11.80
|
—
|
—
|
—
|
—
|
|
Heart Rate
BrAC = 0.02
|
67.27 BPM
Standard Deviation 14.00
|
63.36 BPM
Standard Deviation 9.00
|
—
|
—
|
—
|
—
|
|
Heart Rate
BrAC = 0.04
|
66.91 BPM
Standard Deviation 10.89
|
61.82 BPM
Standard Deviation 9.16
|
—
|
—
|
—
|
—
|
|
Heart Rate
BrAC = 0.06
|
66.64 BPM
Standard Deviation 12.83
|
63.09 BPM
Standard Deviation 9.82
|
—
|
—
|
—
|
—
|
|
Heart Rate
BrAC = 0.08
|
66.36 BPM
Standard Deviation 12.37
|
61.27 BPM
Standard Deviation 8.21
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dlPopulation: All randomized subjects included.
Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Systolic Blood Pressure
1 hour post-med
|
120.64 mmHg
Standard Deviation 11.44
|
116.27 mmHg
Standard Deviation 11.80
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
2 hours post-med
|
121.27 mmHg
Standard Deviation 10.59
|
118.27 mmHg
Standard Deviation 12.48
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
4 hours post-med
|
117 mmHg
Standard Deviation 12.15
|
111.91 mmHg
Standard Deviation 12.85
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
6 hours post-med
|
117.27 mmHg
Standard Deviation 16.17
|
119.55 mmHg
Standard Deviation 15.33
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
8 hours post-med
|
115.18 mmHg
Standard Deviation 13.50
|
107.27 mmHg
Standard Deviation 10.56
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
10 hours post-med
|
116.70 mmHg
Standard Deviation 13.49
|
114.09 mmHg
Standard Deviation 13.63
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
12 hours post-med
|
116.09 mmHg
Standard Deviation 9.17
|
119.63 mmHg
Standard Deviation 7.99
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
16 hours post-med
|
115.64 mmHg
Standard Deviation 17.19
|
115.45 mmHg
Standard Deviation 8.85
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
24 hours post-med
|
122 mmHg
Standard Deviation 11.61
|
122.73 mmHg
Standard Deviation 8.72
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
48 hours post-med
|
122.72 mmHg
Standard Deviation 8.67
|
121.09 mmHg
Standard Deviation 9.47
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
BrAC = 0
|
120.27 mmHg
Standard Deviation 15.07
|
114.36 mmHg
Standard Deviation 12.75
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
BrAC = 0.02
|
118.55 mmHg
Standard Deviation 10.56
|
114.18 mmHg
Standard Deviation 12.34
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
BrAC = 0.04
|
116.55 mmHg
Standard Deviation 12.36
|
111.27 mmHg
Standard Deviation 10.72
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
BrAC = 0.06
|
112.73 mmHg
Standard Deviation 11.40
|
115.18 mmHg
Standard Deviation 14.08
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
BrAC = 0.08
|
112.45 mmHg
Standard Deviation 12.60
|
108.82 mmHg
Standard Deviation 11.50
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
0 hours post-med
|
121 mmHg
Standard Deviation 11.10
|
111.64 mmHg
Standard Deviation 17.35
|
—
|
—
|
—
|
—
|
|
Systolic Blood Pressure
0.5 hours post-med
|
118.64 mmHg
Standard Deviation 10.67
|
117 mmHg
Standard Deviation 12.61
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Post-medication administration (hours): 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48; During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dlPopulation: All randomized subjects included.
Blood pressure (measured in mmHg) will be monitored to determine the safety of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl). Blood pressure is measured at 0, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 48 hours post-medication administration; and during alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl. During the infusion, the times for collecting BP will vary based on how long it takes participants to reach the targeted BrACs.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Diastolic Blood Pressure
0 hours post-med
|
79.64 mmHg
Standard Deviation 10.23
|
75.55 mmHg
Standard Deviation 13.20
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
0.5 hours post-med
|
77.45 mmHg
Standard Deviation 11.44
|
75.18 mmHg
Standard Deviation 11.12
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
1 hour post-med
|
78.82 mmHg
Standard Deviation 10.30
|
74.91 mmHg
Standard Deviation 10.43
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
2 hours post-med
|
79.91 mmHg
Standard Deviation 8.80
|
76.64 mmHg
Standard Deviation 12.14
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
4 hours post-med
|
74.55 mmHg
Standard Deviation 10.82
|
72.18 mmHg
Standard Deviation 10.91
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
6 hours post-med
|
75.36 mmHg
Standard Deviation 14.49
|
74.55 mmHg
Standard Deviation 11.22
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
8 hours post-med
|
72.55 mmHg
Standard Deviation 10.05
|
69.45 mmHg
Standard Deviation 10.46
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
10 hours post-med
|
75.30 mmHg
Standard Deviation 11.88
|
73.82 mmHg
Standard Deviation 12.60
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
12 hours post-med
|
73.64 mmHg
Standard Deviation 9.84
|
77.27 mmHg
Standard Deviation 6.44
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
16 hours post-med
|
72.82 mmHg
Standard Deviation 12.69
|
73.18 mmHg
Standard Deviation 8.81
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
24 hours post-med
|
76.09 mmHg
Standard Deviation 12.39
|
78.09 mmHg
Standard Deviation 10.23
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
48 hours post-med
|
80.55 mmHg
Standard Deviation 10.96
|
81.55 mmHg
Standard Deviation 10.49
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
BrAC = 0
|
78.18 mmHg
Standard Deviation 11.57
|
74.36 mmHg
Standard Deviation 12.49
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
BrAC = 0.02
|
77.91 mmHg
Standard Deviation 10.01
|
73.73 mmHg
Standard Deviation 10.96
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
BrAC = 0.04
|
77.55 mmHg
Standard Deviation 10.71
|
72.91 mmHg
Standard Deviation 11.89
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
BrAC = 0.06
|
75.27 mmHg
Standard Deviation 9.31
|
74.00 mmHg
Standard Deviation 12.13
|
—
|
—
|
—
|
—
|
|
Diastolic Blood Pressure
BrAC = 0.08
|
71.91 mmHg
Standard Deviation 10.90
|
72.73 mmHg
Standard Deviation 10.75
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.Population: All randomized subjects included.
Subjective effects of alcohol will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (1 = strongly disagree, 7 = strongly agree).
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)
BrAC = 0.00
|
2.58 scores on a scale
Standard Deviation 1.74
|
2.90 scores on a scale
Standard Deviation 2.04
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)
BrAC = 0.02
|
3.14 scores on a scale
Standard Deviation 1.64
|
3.27 scores on a scale
Standard Deviation 1.65
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)
BrAC = 0.04
|
3.02 scores on a scale
Standard Deviation 1.64
|
3.19 scores on a scale
Standard Deviation 1.60
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)
BrAC = 0.06
|
2.73 scores on a scale
Standard Deviation 2.00
|
2.60 scores on a scale
Standard Deviation 1.60
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)
BrAC = 0.08
|
2.83 scores on a scale
Standard Deviation 1.79
|
2.91 scores on a scale
Standard Deviation 1.87
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.Population: All randomized subjects included.
Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you feel any drug effects?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale
BrAC = 0.00
|
1.36 scores on a scale
Standard Deviation 2.66
|
0.91 scores on a scale
Standard Deviation 1.30
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale
BrAC = 0.02
|
2.73 scores on a scale
Standard Deviation 2.45
|
3.45 scores on a scale
Standard Deviation 2.21
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale
BrAC = 0.04
|
3.82 scores on a scale
Standard Deviation 2.75
|
4.82 scores on a scale
Standard Deviation 3.03
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale
BrAC = 0.06
|
4.45 scores on a scale
Standard Deviation 3.48
|
5.36 scores on a scale
Standard Deviation 3.33
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale
BrAC = 0.08
|
5.27 scores on a scale
Standard Deviation 3.29
|
6.36 scores on a scale
Standard Deviation 2.80
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.Population: All randomized subjects included.
Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Do you like the effects you are feeling right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale
BrAC = 0.00
|
4.09 scores on a scale
Standard Deviation 1.70
|
4.09 scores on a scale
Standard Deviation 2.02
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale
BrAC = 0.02
|
5.36 scores on a scale
Standard Deviation 1.63
|
5.36 scores on a scale
Standard Deviation 3.20
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale
BrAC = 0.04
|
6.18 scores on a scale
Standard Deviation 2.52
|
5.55 scores on a scale
Standard Deviation 2.95
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale
BrAC = 0.06
|
6.64 scores on a scale
Standard Deviation 2.98
|
6.36 scores on a scale
Standard Deviation 3.44
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale
BrAC = 0.08
|
6.45 scores on a scale
Standard Deviation 3.33
|
6.27 scores on a scale
Standard Deviation 3.50
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.Population: All randomized subjects included.
Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Would you like more of the drug right now?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale
BrAC = 0.00
|
1.64 scores on a scale
Standard Deviation 2.25
|
3.18 scores on a scale
Standard Deviation 4.00
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale
BrAC = 0.02
|
4.91 scores on a scale
Standard Deviation 4.09
|
6.27 scores on a scale
Standard Deviation 4.52
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale
BrAC = 0.04
|
5.45 scores on a scale
Standard Deviation 3.96
|
6.00 scores on a scale
Standard Deviation 3.95
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale
BrAC = 0.06
|
5.00 scores on a scale
Standard Deviation 3.92
|
5.64 scores on a scale
Standard Deviation 4.03
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale
BrAC = 0.08
|
5.27 scores on a scale
Standard Deviation 4.25
|
5.55 scores on a scale
Standard Deviation 4.78
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.Population: All randomized subjects included.
Subjective effects of alcohol will be measured using the Drug Effects Questionnaire, which consists of 4 items that capture subjective effects, (feeling effects, liking effects, wanting more and being high). The question "Are you high?" was rated on an 11 point scale from 0 to 10 (higher values represent more effects).
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale
BrAC = 0.02
|
2.64 scores on a scale
Standard Deviation 2.29
|
3.27 scores on a scale
Standard Deviation 2.01
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale
BrAC = 0.00
|
0.91 scores on a scale
Standard Deviation 1.70
|
0.09 scores on a scale
Standard Deviation 0.30
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale
BrAC = 0.04
|
4.00 scores on a scale
Standard Deviation 2.93
|
5.36 scores on a scale
Standard Deviation 2.66
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale
BrAC = 0.06
|
4.91 scores on a scale
Standard Deviation 3.56
|
5.73 scores on a scale
Standard Deviation 2.57
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale
BrAC = 0.08
|
5.09 scores on a scale
Standard Deviation 3.62
|
6.00 scores on a scale
Standard Deviation 2.79
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.Population: All randomized subjects included.
Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Stimulant Subscale ranges from 0 to 70. Mean scores across all subjects are reported below.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale
BrAC = 0.00
|
18.09 scores on a scale
Standard Deviation 13.37
|
17.36 scores on a scale
Standard Deviation 12.99
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale
BrAC = 0.02
|
20.00 scores on a scale
Standard Deviation 11.91
|
23.73 scores on a scale
Standard Deviation 14.29
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale
BrAC = 0.04
|
21.73 scores on a scale
Standard Deviation 15.04
|
20.09 scores on a scale
Standard Deviation 13.32
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale
BrAC = 0.06
|
25.91 scores on a scale
Standard Deviation 19.03
|
22.64 scores on a scale
Standard Deviation 15.74
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale
BrAC = 0.08
|
26.18 scores on a scale
Standard Deviation 20.17
|
20.91 scores on a scale
Standard Deviation 15.00
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.02, 0.04, 0.06, 0.08 g/dl period; which is expected to last approximately 6 hours.Population: All randomized subjects included.
Subjective effects of alcohol will be measured using the Biphasic Alcohol Effects Scale (BAES) , which consists of 14 items designed to capture the stimulant and sedative effects of alcohol, each rated on an 11-point scale (0 = not at all, 10 = extremely). The total score for the Sedative Subscale ranges from 0 to 70. Mean scores across subjects are reported below.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale
BrAC = 0.00
|
14.18 scores on a scale
Standard Deviation 14.67
|
10.64 scores on a scale
Standard Deviation 9.97
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale
BrAC = 0.02
|
11.00 scores on a scale
Standard Deviation 13.10
|
13.09 scores on a scale
Standard Deviation 14.80
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale
BrAC = 0.04
|
10.91 scores on a scale
Standard Deviation 14.72
|
16.00 scores on a scale
Standard Deviation 15.75
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale
BrAC = 0.06
|
15.27 scores on a scale
Standard Deviation 17.41
|
16.73 scores on a scale
Standard Deviation 19.22
|
—
|
—
|
—
|
—
|
|
Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale
BrAC = 0.08
|
15.27 scores on a scale
Standard Deviation 18.93
|
16.64 scores on a scale
Standard Deviation 17.32
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 6 hours post-medication administrationCue-induced craving will be measured using the Alcohol Urge Questionnaire (AUQ), which consists of 8 items associated with urge to drink alcohol, rated on a 7 point scale (0 = strongly disagree, 6 = strongly agree). Item scores were averaged and the total score also ranges from 0-6.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)
|
3.59 scores on a scale
Standard Deviation 1.69
|
4.07 scores on a scale
Standard Deviation 1.34
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dlPopulation: All randomized subjects included.
Adverse effects will be monitored to determine the safe of combining IVM (30 mg) with moderate doses of alcohol (0.08 g/dl) using the Systematic Assessment for Treatment Emergent Effects (SAFTEE). The SAFTEE is a 24-item checklist in which the participant can identify whether a symptom is present (yes/no), its severity (mild, moderate, severe) and whether it was caused by the medication (yes/no). Data below represents a count of individual adverse effects reported on the SAFTEE during the alcohol infusion.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
n=11 Participants
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
n=11 Participants
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Adverse Effects
Abdominal pain/cramps
|
0 adverse effect count
|
1 adverse effect count
|
1 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Yellow eyes
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Nausea or vomiting
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Irritability or anger
|
1 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Increased desire for sex
|
1 adverse effect count
|
0 adverse effect count
|
1 adverse effect count
|
1 adverse effect count
|
2 adverse effect count
|
1 adverse effect count
|
|
Adverse Effects
Nervousness
|
1 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
1 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Ringing in the ears
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Decrease in appetite
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Depression
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Fatigue
|
1 adverse effect count
|
2 adverse effect count
|
2 adverse effect count
|
1 adverse effect count
|
1 adverse effect count
|
2 adverse effect count
|
|
Adverse Effects
Difficulty in staying awake
|
3 adverse effect count
|
3 adverse effect count
|
4 adverse effect count
|
3 adverse effect count
|
2 adverse effect count
|
2 adverse effect count
|
|
Adverse Effects
Increase in appetite
|
0 adverse effect count
|
1 adverse effect count
|
3 adverse effect count
|
1 adverse effect count
|
2 adverse effect count
|
4 adverse effect count
|
|
Adverse Effects
Blurred vision
|
1 adverse effect count
|
1 adverse effect count
|
1 adverse effect count
|
0 adverse effect count
|
1 adverse effect count
|
1 adverse effect count
|
|
Adverse Effects
Drowsiness
|
2 adverse effect count
|
4 adverse effect count
|
2 adverse effect count
|
2 adverse effect count
|
4 adverse effect count
|
5 adverse effect count
|
|
Adverse Effects
Headache
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
1 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Night sweats
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Mental confusion
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Anxiety
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
1 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Joint or muscle pain
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Dizziness
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
1 adverse effect count
|
2 adverse effect count
|
|
Adverse Effects
Sexual problems
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Difficulty sleeping
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Fever or chills
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
|
Adverse Effects
Decreased desire for sex
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
0 adverse effect count
|
SECONDARY outcome
Timeframe: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48Population: All randomized subjects included.
This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Maximum plasma concentration (Cmax), measured in ng/mL, provided below.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Ivermectin Pharmacokinetics: Peak Concentration (Cmax)
|
406.03 ng/mL
Standard Deviation 398.36
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48Population: All randomized subjects included.
This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Time to Cmax (Tmax), measured in hours, provided below.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Ivermectin Pharmacokinetics: Time to Cmax (Tmax)
|
9.09 hours
Standard Deviation 3.62
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48Population: All randomized subjects included.
This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Area under the time-concentration curve (AUC) from 0 to 48 hours after IVM administration, provided below.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)
|
5078 ng*h/mL
Standard Deviation 4258
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48This study will collect blood samples for pharmacokinetic (PK) and pharmacodynamic profiling in order to examine whether IVM metabolism corresponds to its effects on alcohol response. Half-life of ivermectin (T1/2), measured in hours, provided below.
Outcome measures
| Measure |
Placebo
n=11 Participants
Single dose sugar pill, matched to active medication.
|
IVM 30mg
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
|
Placebo (BrAC = 0.08)
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
IVM 30mg (BrAC = 0.00)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
|
IVM 30mg (BrAC = 0.04)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
|
IVM 30mg (BrAC = 0.08)
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
|
|---|---|---|---|---|---|---|
|
Ivermectin Pharmacokinetics: Half-life (T1/2)
|
15.75 hours
Standard Deviation 6.86
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: pre-post exposure to an imaginal stress scriptPopulation: The stress paradigm (pre-post exposure to an imaginal stress script) was not implemented from the outset of the study due to feasibility reasons. In particular, the investigators were concerned that the timing of the stress exposure might contaminate the effects of the alcohol administration.
Alcohol Urge Questionnaire (AUQ)
Outcome measures
Outcome data not reported
Adverse Events
IVM 30mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place