Trial Outcomes & Findings for Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers (NCT NCT01779024)
NCT ID: NCT01779024
Last Updated: 2018-08-03
Results Overview
The total number of alcohol infusions self-administered.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
120 minutes after the start of the infusion
Results posted on
2018-08-03
Participant Flow
Participant milestones
| Measure |
Ghrelin, Then Placebo
Intravenous acyl-ghrelin a loading dose (3 mcg/kg), followed by a continuous infusion (16.9 ng/kg/min)\] was administered on the first visit; Intravenous placebo \[packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor\] was administered on the second visit.
|
Placebo, Then Ghrelin
Intravenous placebo packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor\] was administered on the first visit; Intravenous acyl-ghrelin \[a loading dose (3 mcg/kg), followed by a continuous infusion (16.9 ng/kg/min)\] was administered on the second visit
|
|---|---|---|
|
1st Visit - Alcohol Self-Administration
STARTED
|
8
|
9
|
|
1st Visit - Alcohol Self-Administration
COMPLETED
|
8
|
9
|
|
1st Visit - Alcohol Self-Administration
NOT COMPLETED
|
0
|
0
|
|
2nd Visit - Alcohol Self-Administration
STARTED
|
8
|
9
|
|
2nd Visit - Alcohol Self-Administration
COMPLETED
|
6
|
9
|
|
2nd Visit - Alcohol Self-Administration
NOT COMPLETED
|
2
|
0
|
|
1st Visit - Functional MRI
STARTED
|
6
|
7
|
|
1st Visit - Functional MRI
COMPLETED
|
4
|
5
|
|
1st Visit - Functional MRI
NOT COMPLETED
|
2
|
2
|
|
2nd Visit - Functional MRI
STARTED
|
5
|
6
|
|
2nd Visit - Functional MRI
COMPLETED
|
5
|
6
|
|
2nd Visit - Functional MRI
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ghrelin for Alcohol Use in Non-Treatment-Seeking Heavy Drinkers
Baseline characteristics by cohort
| Measure |
All Study Participants
n=17 Participants
Participants who were randomized to receive either Ghrelin or Placebo
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 120 minutes after the start of the infusionPopulation: The analyses included only those subjects who completed all types of infusions (Ghrelin and Placebo) and had alcohol self-administration
The total number of alcohol infusions self-administered.
Outcome measures
| Measure |
Ghrelin
n=11 Participants
Intravenous acyl-ghrelin a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)\] was administered on the first ASA visit; Intravenous placebo \[packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor\] was administered on the second ASA visit.
|
Placebo
n=11 Participants
Intravenous placebo packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor\] was administered on the first ASA visit; Intravenous acyl-ghrelin \[a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)\] was administered on the second ASA visit
|
|---|---|---|
|
Alcohol Infusions Self-administered
|
10.45 Number of alcohol infusions
Standard Error 1.15
|
8.80 Number of alcohol infusions
Standard Error 1.29
|
Adverse Events
Ghrelin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ghrelin
n=17 participants at risk
Intravenous acyl-ghrelin a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)\] was administered on the first visit; Intravenous placebo \[packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor\] was administered on the second visit.
|
Placebo
n=17 participants at risk
Intravenous placebo packed in Dextrose 5% / Water USP 50mL bags and made identical to ghrelin in terms of appearance, texture, and odor\] was administered on the first visit; Intravenous acyl-ghrelin \[a loading dose (3 mcg/kg), followed by a continous infusion (16.9 ng/kg/min)\] was administered on the second visit
|
|---|---|---|
|
Cardiac disorders
Dizziness
|
11.8%
2/17 • 240 minutes
|
23.5%
4/17 • 240 minutes
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/17 • 240 minutes
|
5.9%
1/17 • 240 minutes
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/17 • 240 minutes
|
5.9%
1/17 • 240 minutes
|
|
Gastrointestinal disorders
Nausea
|
11.8%
2/17 • 240 minutes
|
0.00%
0/17 • 240 minutes
|
|
General disorders
Asthenia
|
0.00%
0/17 • 240 minutes
|
5.9%
1/17 • 240 minutes
|
|
General disorders
Decreased appetite
|
5.9%
1/17 • 240 minutes
|
0.00%
0/17 • 240 minutes
|
|
General disorders
Fatigue
|
29.4%
5/17 • 240 minutes
|
5.9%
1/17 • 240 minutes
|
|
General disorders
Feeling hot
|
5.9%
1/17 • 240 minutes
|
0.00%
0/17 • 240 minutes
|
|
General disorders
Flushing
|
5.9%
1/17 • 240 minutes
|
0.00%
0/17 • 240 minutes
|
|
General disorders
Hyperhidrosis
|
11.8%
2/17 • 240 minutes
|
11.8%
2/17 • 240 minutes
|
|
General disorders
Increased Appetite
|
58.8%
10/17 • 240 minutes
|
29.4%
5/17 • 240 minutes
|
|
Nervous system disorders
Headache
|
5.9%
1/17 • 240 minutes
|
5.9%
1/17 • 240 minutes
|
|
Nervous system disorders
Memory impairment
|
11.8%
2/17 • 240 minutes
|
5.9%
1/17 • 240 minutes
|
|
Nervous system disorders
Somnolence
|
41.2%
7/17 • 240 minutes
|
35.3%
6/17 • 240 minutes
|
|
Psychiatric disorders
Euphoric mood
|
35.3%
6/17 • 240 minutes
|
17.6%
3/17 • 240 minutes
|
Additional Information
Leggio, Lorenzo
National Institute on Alcohol Abuse and Alcoholism
Phone: +1 301 435 9398
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place