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Trial record 9 of 106 for:    IVERMECTIN

Development of Ivermectin for Alcohol Use Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046200
Recruitment Status : Completed
First Posted : January 27, 2014
Results First Posted : April 13, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Lara Ray, PhD, University of California, Los Angeles

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Alcohol Use Disorder
Interventions Drug: Ivermectin
Drug: Placebo
Drug: Alcohol
Enrollment 11
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IVM 30mg First, Then Placebo Placebo First, Then IVM 30 mg
Hide Arm/Group Description

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.

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.

Period Title: First Intervention (1 Day)
Started 5 6
Completed 5 6
Not Completed 0 0
Period Title: Second Intervention (1 Day)
Started 5 6
Completed 5 6
Not Completed 0 0
Arm/Group Title IVM 30mg; Placebo
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants
38.82  (11.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
2
  18.2%
Male
9
  81.8%
Meets criteria for DSM-V AD  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 11 participants
11
1.Primary Outcome
Title Heart Rate
Hide Description

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.

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: BPM
0 hours post-med 64.57  (9.74) 68.36  (20.47)
0.5 hours post-med 66.82  (10.91) 62.82  (11.46)
1 hour post-med 66.09  (12.01) 64.27  (11.60)
2 hours post-med 65.18  (13.88) 61.18  (11.03)
4 hours post-med 66.73  (10.60) 61.55  (12.36)
6 hours post-med 63.27  (12.66) 59.73  (12.62)
8 hours post-med 66.36  (13.44) 62.18  (11.76)
10 hours post-med 64.70  (14.33) 62.64  (10.19)
12 hours post-med 72.45  (13.41) 73.64  (9.31)
16 hours post-med 61.18  (12.08) 58.09  (10.97)
24 hours post-med 62.55  (11.09) 64.64  (10.58)
48 hours post-med 69.18  (10.15) 69.45  (12.49)
BrAC = 0 63.09  (12.69) 61.00  (11.80)
BrAC = 0.02 67.27  (14.00) 63.36  (9.00)
BrAC = 0.04 66.91  (10.89) 61.82  (9.16)
BrAC = 0.06 66.64  (12.83) 63.09  (9.82)
BrAC = 0.08 66.36  (12.37) 61.27  (8.21)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0563
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
2.Primary Outcome
Title Systolic Blood Pressure
Hide Description

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.

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: mmHg
0 hours post-med 121  (11.10) 111.64  (17.35)
0.5 hours post-med 118.64  (10.67) 117  (12.61)
1 hour post-med 120.64  (11.44) 116.27  (11.80)
2 hours post-med 121.27  (10.59) 118.27  (12.48)
4 hours post-med 117  (12.15) 111.91  (12.85)
6 hours post-med 117.27  (16.17) 119.55  (15.33)
8 hours post-med 115.18  (13.50) 107.27  (10.56)
10 hours post-med 116.70  (13.49) 114.09  (13.63)
12 hours post-med 116.09  (9.17) 119.63  (7.99)
16 hours post-med 115.64  (17.19) 115.45  (8.85)
24 hours post-med 122  (11.61) 122.73  (8.72)
48 hours post-med 122.72  (8.67) 121.09  (9.47)
BrAC = 0 120.27  (15.07) 114.36  (12.75)
BrAC = 0.02 118.55  (10.56) 114.18  (12.34)
BrAC = 0.04 116.55  (12.36) 111.27  (10.72)
BrAC = 0.06 112.73  (11.40) 115.18  (14.08)
BrAC = 0.08 112.45  (12.60) 108.82  (11.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0342
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Primary Outcome
Title Diastolic Blood Pressure
Hide Description

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.

Time Frame 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
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: mmHg
0 hours post-med 79.64  (10.23) 75.55  (13.20)
0.5 hours post-med 77.45  (11.44) 75.18  (11.12)
1 hour post-med 78.82  (10.30) 74.91  (10.43)
2 hours post-med 79.91  (8.80) 76.64  (12.14)
4 hours post-med 74.55  (10.82) 72.18  (10.91)
6 hours post-med 75.36  (14.49) 74.55  (11.22)
8 hours post-med 72.55  (10.05) 69.45  (10.46)
10 hours post-med 75.30  (11.88) 73.82  (12.60)
12 hours post-med 73.64  (9.84) 77.27  (6.44)
16 hours post-med 72.82  (12.69) 73.18  (8.81)
24 hours post-med 76.09  (12.39) 78.09  (10.23)
48 hours post-med 80.55  (10.96) 81.55  (10.49)
BrAC = 0 78.18  (11.57) 74.36  (12.49)
BrAC = 0.02 77.91  (10.01) 73.73  (10.96)
BrAC = 0.04 77.55  (10.71) 72.91  (11.89)
BrAC = 0.06 75.27  (9.31) 74.00  (12.13)
BrAC = 0.08 71.91  (10.90) 72.73  (10.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1597
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Primary Outcome
Title Subjective Effects of Alcohol Using the Alcohol Urge Questionnaire (AUQ)
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BrAC = 0.00 2.58  (1.74) 2.90  (2.04)
BrAC = 0.02 3.14  (1.64) 3.27  (1.65)
BrAC = 0.04 3.02  (1.64) 3.19  (1.60)
BrAC = 0.06 2.73  (2.00) 2.60  (1.60)
BrAC = 0.08 2.83  (1.79) 2.91  (1.87)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7617
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Primary Outcome
Title Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Feel" Subscale
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BrAC = 0.00 1.36  (2.66) 0.91  (1.30)
BrAC = 0.02 2.73  (2.45) 3.45  (2.21)
BrAC = 0.04 3.82  (2.75) 4.82  (3.03)
BrAC = 0.06 4.45  (3.48) 5.36  (3.33)
BrAC = 0.08 5.27  (3.29) 6.36  (2.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Primary Outcome
Title Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "Like" Subscale
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BrAC = 0.00 4.09  (1.70) 4.09  (2.02)
BrAC = 0.02 5.36  (1.63) 5.36  (3.20)
BrAC = 0.04 6.18  (2.52) 5.55  (2.95)
BrAC = 0.06 6.64  (2.98) 6.36  (3.44)
BrAC = 0.08 6.45  (3.33) 6.27  (3.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Primary Outcome
Title Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "More" Subscale
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BrAC = 0.00 1.64  (2.25) 3.18  (4.00)
BrAC = 0.02 4.91  (4.09) 6.27  (4.52)
BrAC = 0.04 5.45  (3.96) 6.00  (3.95)
BrAC = 0.06 5.00  (3.92) 5.64  (4.03)
BrAC = 0.08 5.27  (4.25) 5.55  (4.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
8.Primary Outcome
Title Subjective Effects of Alcohol Using the Drug Effects Questionnaire (DEQ) - "High" Subscale
Hide Description 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).
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BrAC = 0.00 0.91  (1.70) 0.09  (0.30)
BrAC = 0.02 2.64  (2.29) 3.27  (2.01)
BrAC = 0.04 4.00  (2.93) 5.36  (2.66)
BrAC = 0.06 4.91  (3.56) 5.73  (2.57)
BrAC = 0.08 5.09  (3.62) 6.00  (2.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.06
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
9.Primary Outcome
Title Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Stimulant Subscale
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BrAC = 0.00 18.09  (13.37) 17.36  (12.99)
BrAC = 0.02 20.00  (11.91) 23.73  (14.29)
BrAC = 0.04 21.73  (15.04) 20.09  (13.32)
BrAC = 0.06 25.91  (19.03) 22.64  (15.74)
BrAC = 0.08 26.18  (20.17) 20.91  (15.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.21
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
10.Primary Outcome
Title Subjective Effects of Alcohol Using the Biphasic Alcohol Effects Scale (BAES) - Sedative Subscale
Hide Description 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.
Time Frame 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.
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
BrAC = 0.00 14.18  (14.67) 10.64  (9.97)
BrAC = 0.02 11.00  (13.10) 13.09  (14.80)
BrAC = 0.04 10.91  (14.72) 16.00  (15.75)
BrAC = 0.06 15.27  (17.41) 16.73  (19.22)
BrAC = 0.08 15.27  (18.93) 16.64  (17.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
11.Primary Outcome
Title Cue-induced Craving Using the Alcohol Urge Questionnaire (AUQ)
Hide Description Cue-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.
Time Frame 6 hours post-medication administration
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo IVM 30mg
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
3.59  (1.69) 4.07  (1.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, IVM 30mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
12.Primary Outcome
Title Adverse Effects
Hide Description 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.
Time Frame During alcohol infusion at BrAC = 0.00, 0.04, 0.08 g/dl
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title Placebo (BrAC = 0.00) Placebo (BrAC = 0.04) Placebo (BrAC = 0.08) IVM 30mg (BrAC = 0.00) IVM 30mg (BrAC = 0.04) IVM 30mg (BrAC = 0.08)
Hide Arm/Group Description:
Single dose sugar pill, matched to active medication. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.04.
Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
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.
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.
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.
Overall Number of Participants Analyzed 11 11 11 11 11 11
Measure Type: Number
Unit of Measure: adverse effect count
Abdominal pain/cramps 0 1 1 0 0 0
Yellow eyes 0 0 0 0 0 0
Nausea or vomiting 0 0 0 0 0 0
Irritability or anger 1 0 0 0 0 0
Increased desire for sex 1 0 1 1 2 1
Nervousness 1 0 0 1 0 0
Ringing in the ears 0 0 0 0 0 0
Decrease in appetite 0 0 0 0 0 0
Depression 0 0 0 0 0 0
Fatigue 1 2 2 1 1 2
Difficulty in staying awake 3 3 4 3 2 2
Increase in appetite 0 1 3 1 2 4
Blurred vision 1 1 1 0 1 1
Drowsiness 2 4 2 2 4 5
Headache 0 0 0 0 1 0
Night sweats 0 0 0 0 0 0
Mental confusion 0 0 0 0 0 0
Anxiety 0 0 0 0 1 0
Joint or muscle pain 0 0 0 0 0 0
Dizziness 0 0 0 0 1 2
Sexual problems 0 0 0 0 0 0
Difficulty sleeping 0 0 0 0 0 0
Fever or chills 0 0 0 0 0 0
Decreased desire for sex 0 0 0 0 0 0
13.Secondary Outcome
Title Ivermectin Pharmacokinetics: Peak Concentration (Cmax)
Hide Description 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.
Time Frame Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
Hide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title IVM 30mg
Hide Arm/Group Description:
Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng/mL
406.03  (398.36)
14.Secondary Outcome
Title Ivermectin Pharmacokinetics: Time to Cmax (Tmax)
Hide Description 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.
Time Frame Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
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All randomized subjects included.
Arm/Group Title IVM 30mg
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Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: hours
9.09  (3.62)
15.Secondary Outcome
Title Ivermectin Pharmacokinetics: Area Under the Time-concentration Curve (AUC)
Hide Description 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.
Time Frame Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
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Hide Analysis Population Description
All randomized subjects included.
Arm/Group Title IVM 30mg
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Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: ng*h/mL
5078  (4258)
16.Secondary Outcome
Title Ivermectin Pharmacokinetics: Half-life (T1/2)
Hide Description 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. Half-life of ivermectin (T1/2), measured in hours, provided below.
Time Frame Hours post-drug administration: 0, 0.5, 1, 2, 4, 6, 8, 10, 12, 16, 24, 48
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[Not Specified]
Arm/Group Title IVM 30mg
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Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: hours
15.75  (6.86)
17.Secondary Outcome
Title Stress-induced Alcohol Craving
Hide Description Alcohol Urge Questionnaire (AUQ)
Time Frame pre-post exposure to an imaginal stress script
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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.
Arm/Group Title Placebo IVM 30mg
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Single dose sugar pill, matched to active medication.
Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVM 30mg Placebo
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Ivermectin 30 mg single dose

Ivermectin: Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.

Alcohol

Matched placebo, single dose

Placebo: sugar pill

Alcohol

All-Cause Mortality
IVM 30mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
IVM 30mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
IVM 30mg Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)   0/11 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Dr. Lara Ray
Organization: UCLA Department of Psychology
Phone: 310-794-5383
EMail: lararay@psych.ucla.edu
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Responsible Party: Lara Ray, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02046200     History of Changes
Other Study ID Numbers: IVM
UL1TR000124 ( U.S. NIH Grant/Contract )
First Submitted: January 14, 2014
First Posted: January 27, 2014
Results First Submitted: November 3, 2016
Results First Posted: April 13, 2017
Last Update Posted: August 8, 2018