Trial Outcomes & Findings for Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1 (NCT NCT00218491)
NCT ID: NCT00218491
Last Updated: 2019-01-15
Results Overview
Drug and placebo compliance were measured by urine riboflavin levels. Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
8 weeks
Results posted on
2019-01-15
Participant Flow
Participant milestones
| Measure |
1200mg N-Acetylcysteine
1200mg N-Acetylcysteine
N-Acetylcysteine: 1200mg N-Acetylcysteine
|
2400mg N-Acetylcysteine
2400mg N-Acetylcysteine
N-Acetylcysteine: 2400mg N-Acetylcysteine
|
Matching Placebo
Matching Placebo: Matching Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
40
|
33
|
38
|
|
Overall Study
COMPLETED
|
40
|
33
|
38
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of N-Acetylcysteine (NAC) in Treating Cocaine Dependent Individuals - 1
Baseline characteristics by cohort
| Measure |
1200mg N-Acetylcysteine
n=40 Participants
1200mg N-Acetylcysteine
N-Acetylcysteine: 1200mg N-Acetylcysteine
|
2400mg N-Acetylcysteine
n=33 Participants
2400mg N-Acetylcysteine
N-Acetylcysteine: 2400mg N-Acetylcysteine
|
Matching Placebo
n=38 Participants
Matching Placebo
Matching Placebo: Matching Placebo
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 10.1 • n=93 Participants
|
43.3 years
STANDARD_DEVIATION 13.6 • n=4 Participants
|
42.8 years
STANDARD_DEVIATION 8.7 • n=27 Participants
|
43.2 years
STANDARD_DEVIATION 9.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
83 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 8 weeksDrug and placebo compliance were measured by urine riboflavin levels. Study compliance was defined as 80% or greater weekly urine riboflavin levels equal to or greater than 1500 ng/ml
Outcome measures
| Measure |
1200mg N-Acetylcysteine
n=40 Participants
1200mg N-Acetylcysteine
N-Acetylcysteine: 1200mg N-Acetylcysteine
|
2400mg N-Acetylcysteine
n=33 Participants
2400mg N-Acetylcysteine
N-Acetylcysteine: 2400mg N-Acetylcysteine
|
Matching Placebo
n=38 Participants
Matching Placebo: Matching Placebo
|
|---|---|---|---|
|
Number of Participants That Achieved Study Compliance
|
22 Participants
|
15 Participants
|
18 Participants
|
Adverse Events
1200mg N-Acetylcysteine
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
2400mg N-Acetylcysteine
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Matching Placebo
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1200mg N-Acetylcysteine
n=40 participants at risk
1200mg N-Acetylcysteine
N-Acetylcysteine: 1200mg N-Acetylcysteine
|
2400mg N-Acetylcysteine
n=33 participants at risk
2400mg N-Acetylcysteine
N-Acetylcysteine: 2400mg N-Acetylcysteine
|
Matching Placebo
n=38 participants at risk
Matching Placebo: Matching Placebo
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Change in Appetite
|
2.5%
1/40 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
7.9%
3/38 • Number of events 3
|
|
Cardiac disorders
Chest Pain
|
0.00%
0/40
|
6.1%
2/33 • Number of events 2
|
0.00%
0/38
|
|
Skin and subcutaneous tissue disorders
Dermatological episode
|
12.5%
5/40 • Number of events 8
|
12.1%
4/33 • Number of events 4
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Fall
|
2.5%
1/40 • Number of events 1
|
6.1%
2/33 • Number of events 2
|
0.00%
0/38
|
|
Immune system disorders
Fever
|
0.00%
0/40
|
6.1%
2/33 • Number of events 2
|
0.00%
0/38
|
|
Gastrointestinal disorders
GI Event
|
47.5%
19/40 • Number of events 29
|
60.6%
20/33 • Number of events 28
|
42.1%
16/38 • Number of events 23
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event
|
5.0%
2/40 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
18.4%
7/38 • Number of events 8
|
|
General disorders
Sleepiness
|
2.5%
1/40 • Number of events 1
|
12.1%
4/33 • Number of events 5
|
5.3%
2/38 • Number of events 2
|
|
Renal and urinary disorders
Urinary disorder
|
5.0%
2/40 • Number of events 3
|
6.1%
2/33 • Number of events 3
|
5.3%
2/38 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle and Joint Pain
|
10.0%
4/40 • Number of events 4
|
9.1%
3/33 • Number of events 4
|
13.2%
5/38 • Number of events 5
|
|
Psychiatric disorders
Hyperactivity
|
7.5%
3/40 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
5.3%
2/38 • Number of events 2
|
|
General disorders
Headache
|
7.5%
3/40 • Number of events 4
|
9.1%
3/33 • Number of events 3
|
23.7%
9/38 • Number of events 11
|
|
General disorders
Insomnia
|
5.0%
2/40 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
5.3%
2/38 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place