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.
COMPLETED
NA
45 participants
approximately 30 minutes after drug administration
2014-05-15
Participant Flow
Individuals were recruited via advertisements in local public transportation and mass-media
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
| 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 administrationWhether 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
| 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 daysWhether ghrelin intravenous (i.v.), as compared to saline i.v., does not significantly increase Adverse Events (AEs).
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 administrationWhether 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
| 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)
Ghrelin (3 Microg/kg)
Saline Solution
Serious adverse events
Adverse event data not reported
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place