Trial Outcomes & Findings for Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment (NCT NCT01675661)
NCT ID: NCT01675661
Last Updated: 2018-05-24
Results Overview
The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
302 participants
Primary outcome timeframe
study weeks 2-13
Results posted on
2018-05-24
Participant Flow
Recruitment occurred almost exclusively through advertising. Individuals currently in treatment for cannabis dependence were not eligible to participate
Participant milestones
| Measure |
NAC Plus CM
N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
Placebo Plus CM
Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
|---|---|---|
|
Overall Study
STARTED
|
153
|
149
|
|
Overall Study
COMPLETED
|
113
|
103
|
|
Overall Study
NOT COMPLETED
|
40
|
46
|
Reasons for withdrawal
| Measure |
NAC Plus CM
N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
Placebo Plus CM
Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
22
|
23
|
|
Overall Study
Practical problems
|
9
|
5
|
|
Overall Study
Moved away
|
5
|
6
|
|
Overall Study
Withdrawal by Subject
|
3
|
7
|
|
Overall Study
Physician Decision
|
0
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Other reason
|
1
|
2
|
Baseline Characteristics
Achieving Cannabis Cessation-Evaluating N-Acetylcysteine Treatment
Baseline characteristics by cohort
| Measure |
NAC Plus CM
n=153 Participants
N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
Placebo Plus CM
n=149 Participants
Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
Total
n=302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 years
STANDARD_DEVIATION 8.74 • n=5 Participants
|
30.8 years
STANDARD_DEVIATION 9.32 • n=7 Participants
|
30.3 years
STANDARD_DEVIATION 9.03 • n=5 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
117 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
122 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
237 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
44 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
176 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
153 participants
n=5 Participants
|
149 participants
n=7 Participants
|
302 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: study weeks 2-13Population: Intent to treat; all participants randomized
The primary outcome is the abstinence rate over the 12 weeks of treatment. Abstinence is based on a weekly urine drug screen confirmed by central laboratory testing and defined as a negative cannabinoid result.
Outcome measures
| Measure |
NAC Plus CM
n=153 Participants
N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
Placebo Plus CM
n=149 Participants
Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
|---|---|---|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 12
|
34 cannabis negative urine tests
|
40 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 2
|
25 cannabis negative urine tests
|
21 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 3
|
30 cannabis negative urine tests
|
22 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 4
|
33 cannabis negative urine tests
|
36 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 5
|
32 cannabis negative urine tests
|
33 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 6
|
32 cannabis negative urine tests
|
30 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 7
|
36 cannabis negative urine tests
|
37 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 8
|
40 cannabis negative urine tests
|
37 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 9
|
39 cannabis negative urine tests
|
36 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 10
|
39 cannabis negative urine tests
|
37 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 11
|
38 cannabis negative urine tests
|
36 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Study Week 13
|
33 cannabis negative urine tests
|
36 cannabis negative urine tests
|
|
The Odds of Negative Urine Cannabinoid Tests During Treatment.
Overall
|
410 cannabis negative urine tests
|
401 cannabis negative urine tests
|
Adverse Events
NAC Plus CM
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Placebo Plus CM
Serious events: 6 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NAC Plus CM
n=153 participants at risk
N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
Placebo Plus CM
n=149 participants at risk
Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Infections and infestations
Cellulitis
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Cardiac disorders
Irregular Heart Rate
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
Other adverse events
| Measure |
NAC Plus CM
n=153 participants at risk
N-acetylcysteine (NAC) plus Contingency Management (CM)
N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
Placebo Plus CM
n=149 participants at risk
Placebo plus Contingency Management (CM)
Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
4.6%
7/153 • Number of events 7 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
6.7%
10/149 • Number of events 10 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Diarrhea
|
5.2%
8/153 • Number of events 8 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
5.4%
8/149 • Number of events 8 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
3/153 • Number of events 3 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
3.4%
5/149 • Number of events 5 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Dyspepsia
|
2.0%
3/153 • Number of events 3 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
1.3%
2/149 • Number of events 2 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
2/153 • Number of events 2 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Vomiting
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Reflux disease
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Nervous system disorders
Headache
|
6.5%
10/153 • Number of events 10 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
10.1%
15/149 • Number of events 15 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Nervous system disorders
Dizziness
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
1.3%
2/149 • Number of events 2 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Psychiatric disorders
Insomnia
|
1.3%
2/153 • Number of events 2 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Psychiatric disorders
Panic attack
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Psychiatric disorders
Elevated mood
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Psychiatric disorders
Depression
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Psychiatric disorders
Alcohol abuse
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Back Injury
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
General disorders
Fatigue
|
1.3%
2/153 • Number of events 2 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
1.3%
2/149 • Number of events 2 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
General disorders
Feeling abnormal
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
General disorders
Energy increased
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
General disorders
Chest pain
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Infections and infestations
Localized infection
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Infections and infestations
Groin Abscess
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
2.0%
3/153 • Number of events 3 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Vascular disorders
Hypertension
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
1.3%
2/149 • Number of events 2 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Vascular disorders
Flushing
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Investigations
Blood pressure increased
|
0.65%
1/153 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.00%
0/149 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/153 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
0.67%
1/149 • Number of events 1 • Evaluation of adverse events began after informed consent and continued at each weekly visit until the final 13 week follow up visit for all participants.
Participants were asked once a week
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All publications/dissemination products must be reviewed and approved by the Center for Clinical Trials Network (CCTN) Publications Committee before publishing/disseminating.
- Publication restrictions are in place
Restriction type: OTHER