Trial Outcomes & Findings for Effects of Ghrelin on Alcohol Cue Reactivity and Craving (NCT NCT01190085)

NCT ID: NCT01190085

Last Updated: 2014-05-15

Results Overview

Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of urge to drink \[as measured by the Alcohol Visual Analogue Scale (A-VAS)\]. The A-VAS was rated on 11-point anchored Likert-type scales, where 0 is the minimum score (no craving) and 11 is the maximum score (highest craving intensity). The change in the A-VAS score (deltaA-VAS) was used to indicate decrease (-d) or increase (+d) in craving intensity.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

45 participants

Primary outcome timeframe

approximately 30 minutes after drug administration

Results posted on

2014-05-15

Participant Flow

Individuals were recruited via advertisements in local public transportation and mass-media

Participant milestones

Participant milestones
Measure
Ghrelin (1 Microg/kg)
A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Ghrelin (3 Microg/kg)
A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Saline Solution
Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Overall Study
STARTED
13
14
18
Overall Study
COMPLETED
13
14
18
Overall Study
NOT COMPLETED
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Ghrelin on Alcohol Cue Reactivity and Craving

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ghrelin (1 Microg/kg)
n=13 Participants
A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Ghrelin (3 Microg/kg)
n=14 Participants
A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Saline Solution
n=18 Participants
Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Total
n=45 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
0 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
13 Participants
n=5 Participants
14 Participants
n=7 Participants
18 Participants
n=5 Participants
45 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Continuous
42.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
43.9 years
STANDARD_DEVIATION 8.6 • n=7 Participants
46.6 years
STANDARD_DEVIATION 9.0 • n=5 Participants
44.7 years
STANDARD_DEVIATION 9.1 • n=4 Participants
Sex: Female, Male
Female
4 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
16 Participants
n=4 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
9 Participants
n=7 Participants
11 Participants
n=5 Participants
29 Participants
n=4 Participants
Region of Enrollment
United States
13 participants
n=5 Participants
14 participants
n=7 Participants
18 participants
n=5 Participants
45 participants
n=4 Participants

PRIMARY outcome

Timeframe: approximately 30 minutes after drug administration

Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of urge to drink \[as measured by the Alcohol Visual Analogue Scale (A-VAS)\]. The A-VAS was rated on 11-point anchored Likert-type scales, where 0 is the minimum score (no craving) and 11 is the maximum score (highest craving intensity). The change in the A-VAS score (deltaA-VAS) was used to indicate decrease (-d) or increase (+d) in craving intensity.

Outcome measures

Outcome measures
Measure
Ghrelin (1 Microg/kg)
n=13 Participants
A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Ghrelin (3 Microg/kg)
n=14 Participants
A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Saline Solution
n=18 Participants
Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Alcohol Visual Analogue Scale (A-VAS)
1.95 units on a scale
Standard Deviation 2.19
2.66 units on a scale
Standard Deviation 2.19
4.29 units on a scale
Standard Deviation 2.17

PRIMARY outcome

Timeframe: participants will be followed after the cue-reactivity experiment, an expected average of 7 days

Whether ghrelin intravenous (i.v.), as compared to saline i.v., does not significantly increase Adverse Events (AEs).

Outcome measures

Outcome measures
Measure
Ghrelin (1 Microg/kg)
n=13 Participants
A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Ghrelin (3 Microg/kg)
n=14 Participants
A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Saline Solution
n=18 Participants
Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability.
11 participants
12 participants
15 participants

PRIMARY outcome

Timeframe: approximately 30 minutes after drug administration

Whether ghrelin intravenous (i.v.), as compared to saline i.v., dose-dependently results in increased cue-reactivity (CR) responses to alcohol cues in terms of psychophysiological responses, namely salivation changes.

Outcome measures

Outcome measures
Measure
Ghrelin (1 Microg/kg)
n=13 Participants
A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Ghrelin (3 Microg/kg)
n=14 Participants
A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Saline Solution
n=18 Participants
Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Salivation
1.8 gram
Standard Deviation 1.4
1.9 gram
Standard Deviation 1.4
3.2 gram
Standard Deviation 1.4

Adverse Events

Ghrelin (1 Microg/kg)

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Ghrelin (3 Microg/kg)

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Saline Solution

Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Ghrelin (1 Microg/kg)
n=13 participants at risk
A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Ghrelin (3 Microg/kg)
n=14 participants at risk
A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Saline Solution
n=18 participants at risk
Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
Cardiac disorders
fast heart beat
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Increase in appetite
61.5%
8/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
78.6%
11/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
44.4%
8/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Decrease in appetite
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
28.6%
4/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
38.9%
7/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Dizziness
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
28.6%
4/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
16.7%
3/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Eye disorders
Changes in Vision
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
14.3%
2/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Sleepness
15.4%
2/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
14.3%
2/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
22.2%
4/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Fatigue
15.4%
2/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Difficulty with coordination
7.7%
1/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
28.6%
4/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
16.7%
3/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Difficulty with Concentration
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Tingling in Fingers or Toes
7.7%
1/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Word finding Difficulties
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Memory Difficulties
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
16.7%
3/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Change in Taste
7.7%
1/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
7.1%
1/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Tremor
7.7%
1/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
21.4%
3/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
22.2%
4/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Gastrointestinal disorders
Constipation
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
7.1%
1/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Gastrointestinal disorders
Diarrhea
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Gastrointestinal disorders
Nausea
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Headache
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Restlessness
15.4%
2/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
7.1%
1/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
38.9%
7/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Psychiatric disorders
Anxiety
53.8%
7/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
14.3%
2/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
22.2%
4/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Irritability
7.7%
1/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
7.1%
1/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Psychiatric disorders
Mood Disturbance
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
21.4%
3/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
27.8%
5/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Nervous system disorders
Confusion
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
7.1%
1/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Reproductive system and breast disorders
Changes in Libido
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
16.7%
3/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Respiratory, thoracic and mediastinal disorders
Slowed Breathing
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
7.1%
1/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Respiratory, thoracic and mediastinal disorders
Difficulty breathing
7.7%
1/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Respiratory, thoracic and mediastinal disorders
Swelling of throat or tongue
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
7.1%
1/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Skin and subcutaneous tissue disorders
itching
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Renal and urinary disorders
Difficulty passing urine
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Musculoskeletal and connective tissue disorders
Muscle aches
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
22.2%
4/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
Eye disorders
eye pain
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
11.1%
2/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
General disorders
Decreased sweating
0.00%
0/13 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
0.00%
0/14 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.
5.6%
1/18 • Adverse events were collected +17 minutes and +29 minutes after the ghrelin/placebo administration was ended.
The Systematic Assessment for Treatment Emergent Events (SAFTEE) was used for adverse events. For references, see: Levine J, Schooler NR (1986). Psychopharmacology bulletin. 22:343-381; and Johnson BA, Ait-Daoud N, Roache JD (2005). Journal of Studies on Alcohol Supplement.157-167; discussion 140.

Additional Information

Dr. Lorenzo Leggio

Brown University

Phone: 401-863-1000

Results disclosure agreements

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