Trial Outcomes & Findings for Impact of Lofexidine on Stress, Craving and Opioid Use (NCT NCT03718065)
NCT ID: NCT03718065
Last Updated: 2025-02-07
Results Overview
Participants will rate craving on a 0 to 7 Likert scale with 0 indicate "Strongly disagree" that they crave and 7 indicating "strongly agree" that they crave so that higher scores indicate more craving.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
Pre- Cue and 0, 5, 30 and 60 minutes Post-Cue 5 weeks Post- Baseline; Pre-TSST and 0, 5, 30 and 60 minutes Post-TSST 5 weeks Post-Baseline
Results posted on
2025-02-07
Participant Flow
Participant milestones
| Measure |
Lofexidine Men
Men will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Lofexidine Women
Women will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Placebo Men
Men will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
Placebo Women
Women will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
35
|
24
|
24
|
29
|
|
Overall Study
COMPLETED
|
30
|
18
|
23
|
25
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of Lofexidine on Stress, Craving and Opioid Use
Baseline characteristics by cohort
| Measure |
Lofexidine Men
n=35 Participants
Men will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Lofexidine Women
n=24 Participants
Women will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Placebo Men
n=24 Participants
Men will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
Placebo Women
n=29 Participants
Women will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
Total
n=112 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
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
112 Participants
n=21 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
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 9.17 • n=5 Participants
|
35.79 years
STANDARD_DEVIATION 7.34 • n=7 Participants
|
40.71 years
STANDARD_DEVIATION 9.70 • n=5 Participants
|
35.34 years
STANDARD_DEVIATION 7.51 • n=4 Participants
|
37.42 years
STANDARD_DEVIATION 8.65 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
53 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
59 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
34 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
105 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=5 Participants
|
24 participants
n=7 Participants
|
24 participants
n=5 Participants
|
29 participants
n=4 Participants
|
112 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre- Cue and 0, 5, 30 and 60 minutes Post-Cue 5 weeks Post- Baseline; Pre-TSST and 0, 5, 30 and 60 minutes Post-TSST 5 weeks Post-BaselinePopulation: Participants with available data on the Trier Social Stress Task (TSST) or Scripted Imagery Cue (Cue). TSST and Cue Tasks were counterbalanced.
Participants will rate craving on a 0 to 7 Likert scale with 0 indicate "Strongly disagree" that they crave and 7 indicating "strongly agree" that they crave so that higher scores indicate more craving.
Outcome measures
| Measure |
Lofexidine Men
n=27 Participants
Men will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Lofexidine Women
n=19 Participants
Women will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Placebo Men
n=22 Participants
Men will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
Placebo Women
n=23 Participants
Women will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
|---|---|---|---|---|
|
Drug Cue+ Stressor Induced Craving
Pre-Cue
|
1.52 units on a scale
Standard Deviation 1.56
|
1 units on a scale
Standard Deviation 0
|
1.72 units on a scale
Standard Deviation 1.69
|
1.96 units on a scale
Standard Deviation 1.61
|
|
Drug Cue+ Stressor Induced Craving
Cue + 0 Minutes
|
2.33 units on a scale
Standard Deviation 2.06
|
3.58 units on a scale
Standard Deviation 2.97
|
2.05 units on a scale
Standard Deviation 2.10
|
3.56 units on a scale
Standard Deviation 2.54
|
|
Drug Cue+ Stressor Induced Craving
Cue + 5 Minutes
|
2 units on a scale
Standard Deviation 1.75
|
2.74 units on a scale
Standard Deviation 3.02
|
1.86 units on a scale
Standard Deviation 1.73
|
2.83 units on a scale
Standard Deviation 2.35
|
|
Drug Cue+ Stressor Induced Craving
Cue + 30 Minutes
|
1.56 units on a scale
Standard Deviation 1.48
|
1.68 units on a scale
Standard Deviation 1.67
|
1.77 units on a scale
Standard Deviation 1.57
|
2.09 units on a scale
Standard Deviation 2.13
|
|
Drug Cue+ Stressor Induced Craving
Cue + 60 Minutes
|
1.48 units on a scale
Standard Deviation 1.37
|
1.32 units on a scale
Standard Deviation 0.95
|
1.86 units on a scale
Standard Deviation 1.73
|
1.87 units on a scale
Standard Deviation 2.07
|
|
Drug Cue+ Stressor Induced Craving
Pre-TSST
|
1.39 units on a scale
Standard Deviation 0.69
|
1.11 units on a scale
Standard Deviation 0.32
|
1.68 units on a scale
Standard Deviation 1.58
|
2.19 units on a scale
Standard Deviation 2.02
|
|
Drug Cue+ Stressor Induced Craving
TSST + 0 Minutes
|
1.64 units on a scale
Standard Deviation 1.31
|
2.72 units on a scale
Standard Deviation 2.16
|
2.27 units on a scale
Standard Deviation 2.33
|
2.95 units on a scale
Standard Deviation 2.78
|
|
Drug Cue+ Stressor Induced Craving
TSST + 5 Minutes
|
1.64 units on a scale
Standard Deviation 1.45
|
1.89 units on a scale
Standard Deviation 1.23
|
2 units on a scale
Standard Deviation 1.8
|
2.52 units on a scale
Standard Deviation 2.36
|
|
Drug Cue+ Stressor Induced Craving
TSST + 30 Minutes
|
1.36 units on a scale
Standard Deviation 0.95
|
1.18 units on a scale
Standard Deviation 0.39
|
1.82 units on a scale
Standard Deviation 1.59
|
2.33 units on a scale
Standard Deviation 2.27
|
|
Drug Cue+ Stressor Induced Craving
TSST + 60 Minutes
|
1.57 units on a scale
Standard Deviation 1.83
|
1.24 units on a scale
Standard Deviation 0.44
|
1.77 units on a scale
Standard Deviation 1.69
|
2.24 units on a scale
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: Pre- Cue and 0, 5, 30 and 60 minutes Post-Cue 5 weeks Post- Baseline; Pre-TSST and 0, 5, 30 and 60 minutes Post-TSST 5 weeks Post-BaselinePopulation: Participants with available data on the Trier Social Stress Task (TSST) or Scripted Imagery Cue (Cue). TSST and Cue Tasks were counterbalanced.
Participants will rate stress on a 0 to 4 Likert scale with 0 indicate "not at all" and 4 indicating "extremely" so that higher scores indicate a more robust stress response.
Outcome measures
| Measure |
Lofexidine Men
n=27 Participants
Men will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Lofexidine Women
n=19 Participants
Women will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Placebo Men
n=22 Participants
Men will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
Placebo Women
n=21 Participants
Women will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
|---|---|---|---|---|
|
Drug Cue+ Stressor Induced Stress Response
Pre-Cue
|
2.81 units on a scale
Standard Deviation 2.63
|
2.74 units on a scale
Standard Deviation 1.66
|
2.77 units on a scale
Standard Deviation 2.22
|
2.65 units on a scale
Standard Deviation 2.33
|
|
Drug Cue+ Stressor Induced Stress Response
Cue + 0 Minutes
|
3.70 units on a scale
Standard Deviation 2.85
|
5.37 units on a scale
Standard Deviation 2.81
|
3.23 units on a scale
Standard Deviation 2.6
|
3.61 units on a scale
Standard Deviation 2.31
|
|
Drug Cue+ Stressor Induced Stress Response
Cue + 5 Minutes
|
2.78 units on a scale
Standard Deviation 2.53
|
4.16 units on a scale
Standard Deviation 3.08
|
2.68 units on a scale
Standard Deviation 2.06
|
3.09 units on a scale
Standard Deviation 2
|
|
Drug Cue+ Stressor Induced Stress Response
Cue + 30 Minutes
|
2.56 units on a scale
Standard Deviation 2.5
|
2.74 units on a scale
Standard Deviation 2.05
|
2.59 units on a scale
Standard Deviation 2.21
|
2.30 units on a scale
Standard Deviation 1.74
|
|
Drug Cue+ Stressor Induced Stress Response
Cue + 60 Minutes
|
2.63 units on a scale
Standard Deviation 2.64
|
2.38 units on a scale
Standard Deviation 1.45
|
2.64 units on a scale
Standard Deviation 2.34
|
2.61 units on a scale
Standard Deviation 2.19
|
|
Drug Cue+ Stressor Induced Stress Response
Pre-TSST
|
2.57 units on a scale
Standard Deviation 2.15
|
2.61 units on a scale
Standard Deviation 1.75
|
3 units on a scale
Standard Deviation 2.18
|
2.57 units on a scale
Standard Deviation 1.89
|
|
Drug Cue+ Stressor Induced Stress Response
TSST + 0 Minutes
|
4.89 units on a scale
Standard Deviation 3.41
|
5.78 units on a scale
Standard Deviation 2.90
|
3.86 units on a scale
Standard Deviation 2.55
|
4.95 units on a scale
Standard Deviation 3.12
|
|
Drug Cue+ Stressor Induced Stress Response
TSST + 5 Minutes
|
3.54 units on a scale
Standard Deviation 3.05
|
3.61 units on a scale
Standard Deviation 1.97
|
2.82 units on a scale
Standard Deviation 2.26
|
3.10 units on a scale
Standard Deviation 1.87
|
|
Drug Cue+ Stressor Induced Stress Response
TSST + 30 Minutes
|
3.04 units on a scale
Standard Deviation 3.01
|
2.47 units on a scale
Standard Deviation 1.33
|
2.82 units on a scale
Standard Deviation 2.02
|
2.76 units on a scale
Standard Deviation 1.95
|
|
Drug Cue+ Stressor Induced Stress Response
TSST + 60 Minutes
|
2.89 units on a scale
Standard Deviation 2.71
|
2.41 units on a scale
Standard Deviation 1.46
|
2 units on a scale
Standard Deviation 1.95
|
2.52 units on a scale
Standard Deviation 1.47
|
Adverse Events
Lofexidine Men
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Lofexidine Women
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Placebo Men
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Women
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lofexidine Men
n=35 participants at risk
Men will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Lofexidine Women
n=24 participants at risk
Women will receive lofexidine (Lucemyra) for 5 weeks. Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
Lofexidine: Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
|
Placebo Men
n=24 participants at risk
Men will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
Placebo Women
n=29 participants at risk
Women will receive matching placebo for five weeks.
Placebo: Placebo comparator.
|
|---|---|---|---|---|
|
Endocrine disorders
Dry Mouth
|
51.4%
18/35 • Number of events 21 • Baseline to end of study taper- 6 weeks.
|
50.0%
12/24 • Number of events 13 • Baseline to end of study taper- 6 weeks.
|
16.7%
4/24 • Number of events 4 • Baseline to end of study taper- 6 weeks.
|
17.2%
5/29 • Number of events 5 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Tiredness/Drowsiness
|
42.9%
15/35 • Number of events 17 • Baseline to end of study taper- 6 weeks.
|
33.3%
8/24 • Number of events 10 • Baseline to end of study taper- 6 weeks.
|
12.5%
3/24 • Number of events 3 • Baseline to end of study taper- 6 weeks.
|
13.8%
4/29 • Number of events 6 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Dizziness
|
20.0%
7/35 • Number of events 7 • Baseline to end of study taper- 6 weeks.
|
8.3%
2/24 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
8.3%
2/24 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
3.4%
1/29 • Number of events 1 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Headache
|
17.1%
6/35 • Number of events 6 • Baseline to end of study taper- 6 weeks.
|
20.8%
5/24 • Number of events 5 • Baseline to end of study taper- 6 weeks.
|
12.5%
3/24 • Number of events 3 • Baseline to end of study taper- 6 weeks.
|
20.7%
6/29 • Number of events 7 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Fatigue
|
14.3%
5/35 • Number of events 5 • Baseline to end of study taper- 6 weeks.
|
25.0%
6/24 • Number of events 7 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
3.4%
1/29 • Number of events 1 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Nausea
|
8.6%
3/35 • Number of events 3 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
6.9%
2/29 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Lightheadedness
|
8.6%
3/35 • Number of events 3 • Baseline to end of study taper- 6 weeks.
|
8.3%
2/24 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
3.4%
1/29 • Number of events 1 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Sweating
|
8.6%
3/35 • Number of events 3 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/29 • Baseline to end of study taper- 6 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
4.2%
1/24 • Number of events 1 • Baseline to end of study taper- 6 weeks.
|
6.9%
2/29 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Anxiety
|
5.7%
2/35 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
4.2%
1/24 • Number of events 1 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/29 • Baseline to end of study taper- 6 weeks.
|
|
Nervous system disorders
Grogginess
|
5.7%
2/35 • Number of events 2 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/24 • Baseline to end of study taper- 6 weeks.
|
0.00%
0/29 • Baseline to end of study taper- 6 weeks.
|
Additional Information
Dr. Constance Guille
Medical University of South Carolina
Phone: 843-792-6489
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place