Trial Outcomes & Findings for Efficacy of Naltrexone in Women's Smoking Cessation (NCT NCT00271024)
NCT ID: NCT00271024
Last Updated: 2023-03-23
Results Overview
Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
333 participants
Primary outcome timeframe
4 Weeks Following Smoking Quit Date (Study week 7)
Results posted on
2023-03-23
Participant Flow
Enrollment for this study lasted from August 2006-March 2009 with study visits taking place in 3 sites (The University of Chicago, Howard Brown Health Clinic, and the Respiratory Health Association). Follow-up interviews for the study concluded in April 2010.
* N=707 screened for participation (320 met exclusion criteria, 54/387 who passed chose not to participate) * 333 participants were randomized into the trial
Participant milestones
| Measure |
Naltrexone - MALE
Males receiving naltrexone as part of the trial
|
Placebo - MALE
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
80
|
77
|
88
|
88
|
|
Overall Study
Received Study Treatment
|
76
|
71
|
85
|
83
|
|
Overall Study
COMPLETED
|
58
|
51
|
65
|
64
|
|
Overall Study
NOT COMPLETED
|
22
|
26
|
23
|
24
|
Reasons for withdrawal
| Measure |
Naltrexone - MALE
Males receiving naltrexone as part of the trial
|
Placebo - MALE
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Overall Study
Lost Interest
|
3
|
4
|
2
|
3
|
|
Overall Study
Unknown/Unspecified
|
11
|
11
|
8
|
4
|
|
Overall Study
Protocol Violation
|
1
|
6
|
5
|
11
|
|
Overall Study
Unpleasant Reaction To Tablet
|
1
|
3
|
4
|
2
|
|
Overall Study
Time Commitment, Scheduling, or Travel
|
6
|
2
|
4
|
4
|
Baseline Characteristics
Efficacy of Naltrexone in Women's Smoking Cessation
Baseline characteristics by cohort
| Measure |
Naltrexone - MALE
n=80 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=77 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=88 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=88 Participants
Females receiving placebo as part of the trial
|
Total
n=333 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
|
80 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
331 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Continuous
|
38.45 years
STANDARD_DEVIATION 10.97 • n=5 Participants
|
40.21 years
STANDARD_DEVIATION 10.98 • n=7 Participants
|
44.34 years
STANDARD_DEVIATION 11.49 • n=5 Participants
|
44.95 years
STANDARD_DEVIATION 10.45 • n=4 Participants
|
42.13 years
STANDARD_DEVIATION 11.27 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
88 Participants
n=4 Participants
|
176 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
80 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
157 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
80 participants
n=5 Participants
|
77 participants
n=7 Participants
|
88 participants
n=5 Participants
|
88 participants
n=4 Participants
|
333 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 4 Weeks Following Smoking Quit Date (Study week 7)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.
Prolonged Abstinence at 4 weeks post quit date (Study Week 7). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Prolonged Smoking Abstinence: 4 Weeks Post Quit-Date
|
43 Participants
|
29 Participants
|
40 Participants
|
39 Participants
|
PRIMARY outcome
Timeframe: 12 Weeks Following Smoking Quit Date (Study week 15)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.
Prolonged Abstinence at 12 weeks post quit date (Study Week 15). Prolonged Abstinence defined as not smoking (even a puff of a cigarette) at any point during the previous time frame, allowing for a 1-week grace period.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Prolonged Smoking Abstinence: 12 Weeks Post Quit-Date
|
23 Participants
|
12 Participants
|
17 Participants
|
23 Participants
|
PRIMARY outcome
Timeframe: 4 Weeks Following Smoking Quit Date (Study week 7)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.
7-Day Point Prevalence smoking abstinence at 4 weeks post quit date (Study Week 7). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
7-Day Point Prevalence Smoking Abstinence: 4 Weeks Post Quit-Date
|
47 Participants
|
33 Participants
|
49 Participants
|
43 Participants
|
PRIMARY outcome
Timeframe: 12 Weeks Following Smoking Quit Date (Study week 15)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.
7-Day Point Prevalence smoking abstinence at 12 weeks post quit date (Study Week 15). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
7-Day Point Prevalence Smoking Abstinence: 12 Weeks Post Quit-Date
|
31 Participants
|
24 Participants
|
30 Participants
|
31 Participants
|
PRIMARY outcome
Timeframe: 26 Weeks Following Smoking Quit Date (Study week 29)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.
7-Day Point Prevalence smoking abstinence at 29 weeks post quit date (Study Week 29). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
7-Day Point Prevalence Smoking Abstinence: 26 Weeks Post Quit-Date
|
22 Participants
|
18 Participants
|
20 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: 52 Weeks Following Smoking Quit Date (Study week 55)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome.
7-Day Point Prevalence smoking abstinence at 52 weeks post quit date (Study Week 55). 7-Day Point Prevalence abstinence defined as not smoking (even a puff) for seven days in a row or on one day in each of two consecutive weeks during the previous time frame.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
7-Day Point Prevalence Smoking Abstinence: 52 Weeks Post Quit-Date
|
14 Participants
|
15 Participants
|
14 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Weight change at 12 weeks post smoking quit date (study week 15)Population: All participants completing through smoking quit date (study week 3) and who were smoking abstinent at end of treatment (study week 15)
Weight change in lbs at 12 weeks post smoking quit date (study week 15) for only those reporting continued smoking abstinence at the end of treatment. All data are Mean(SEM) and represent positive change, unless otherwise noted. Smoking abstinent for this measure defined as no smoking even 1 puff of a cigarette since the smoking quit date (study week 3), allowing for a 1-week grace period.
Outcome measures
| Measure |
Naltrexone - MALE
n=23 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=12 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=17 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=23 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Weight Change at End of Treatment (Smoking Abstinent Only)
|
4.79 Pounds
Standard Error 0.78
|
5.58 Pounds
Standard Error 0.78
|
2.26 Pounds
Standard Error 0.68
|
5.08 Pounds
Standard Error 0.69
|
SECONDARY outcome
Timeframe: Weight change at 12 weeks post quit date (study week 15) from smoking quit datePopulation: All participants who received study treatment by participating through smoking quit date (Study Week 3)were analyzed for this outcome, regardless of their abstinence status at 12 weeks post quit date (study week 15)
Weight change at 12 weeks post quit date (study week 15) for the whole sample regardless of quit status. All data is Mean(SEM) and represents a positive change unless otherwise noted.
Outcome measures
| Measure |
Naltrexone - MALE
n=154 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=161 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Weight Change at End of Treatment (Regardless of Quit Status)
|
5.29 Pounds
Standard Error 0.52
|
3.42 Pounds
Standard Error 0.53
|
—
|
—
|
SECONDARY outcome
Timeframe: 1-Week Post Quit Date (Study Week 4)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.
Participants reporting side effects during the previous week by pill type and sex, 1-week following quit date (Study week 4). Participants rated side effects experienced by None, Mild, or Severe.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Increased Sexual Desire - "Severe"
|
2 Participants
|
6 Participants
|
1 Participants
|
0 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Insomnia - "Mild"
|
13 Participants
|
16 Participants
|
19 Participants
|
12 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Insomnia - "Severe"
|
2 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Constipation - "Mild"
|
18 Participants
|
20 Participants
|
24 Participants
|
14 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Diarrhea - "Mild"
|
6 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Diarrhea - "Severe"
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Joint or Muscle Pain - "Mild"
|
21 Participants
|
21 Participants
|
14 Participants
|
13 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Nausea - "Mild"
|
16 Participants
|
5 Participants
|
24 Participants
|
13 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Nausea - "Severe"
|
4 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Vomiting - "Mild"
|
3 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Vomiting - "Severe"
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Headache- "Mild"
|
28 Participants
|
17 Participants
|
31 Participants
|
33 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Headache - "Severe"
|
4 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Light Headed/Dizzy - "Mild"
|
22 Participants
|
16 Participants
|
25 Participants
|
17 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Light Headed/Dizzy - "Severe"
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Flushed/Warm - "Mild"
|
12 Participants
|
9 Participants
|
24 Participants
|
15 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Flushed/Warm - "Severe"
|
1 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Tiredness - "Mild"
|
42 Participants
|
34 Participants
|
38 Participants
|
33 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Tiredness - "Severe"
|
5 Participants
|
7 Participants
|
10 Participants
|
9 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Anxiety/Agitation - "Mild"
|
33 Participants
|
35 Participants
|
31 Participants
|
32 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Anxiety/Agitation - "Severe"
|
3 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Increased Sexual Desire - "Mild"
|
10 Participants
|
22 Participants
|
9 Participants
|
6 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Constipation - "Severe"
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
|
Opioid Antagonist Reported Side Effects: 1-Week Post Quit Date
Joint or Muscle Pain - "Severe"
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 4-Weeks Post Quit Date (Study Week 7)Population: All participants who received study treatment by participating through smoking quit date (Study Week 3) were analyzed for this outcome.
Participants reporting side effects during the previous week by pill type and sex, 4-weeks following quit date (Study week 7). Participants rated side effects experienced by None, Mild, or Severe.
Outcome measures
| Measure |
Naltrexone - MALE
n=76 Participants
Males receiving naltrexone as part of the trial
|
Placebo - MALE
n=71 Participants
Males receiving placebo as part of the trial
|
Naltrexone - FEMALE
n=85 Participants
Females receiving naltrexone as part of the trial
|
Placebo - FEMALE
n=83 Participants
Females receiving placebo as part of the trial
|
|---|---|---|---|---|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Flushed/Warm - "Mild"
|
6 Participants
|
5 Participants
|
22 Participants
|
14 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Flushed/Warm - "Severe"
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Tiredness - "Mild"
|
27 Participants
|
27 Participants
|
32 Participants
|
24 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Tiredness - "Severe"
|
2 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Anxiety/Agitation - "Severe"
|
2 Participants
|
3 Participants
|
4 Participants
|
3 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Increased Sexual Desire - "Mild"
|
25 Participants
|
17 Participants
|
11 Participants
|
7 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Increased Sexual Desire - "Severe"
|
2 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Insomnia - "Mild"
|
10 Participants
|
13 Participants
|
17 Participants
|
10 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Insomnia - "Severe"
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Constipation - "Mild"
|
13 Participants
|
8 Participants
|
18 Participants
|
10 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Diarrhea - "Mild"
|
7 Participants
|
11 Participants
|
6 Participants
|
4 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Joint or Muscle Pain - "Severe"
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Constipation - "Severe"
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Diarrhea - "Severe"
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Joint or Muscle Pain - "Mild"
|
17 Participants
|
15 Participants
|
15 Participants
|
16 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Nausea - "Mild"
|
3 Participants
|
3 Participants
|
12 Participants
|
7 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Nausea - "Severe"
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Vomiting - "Mild"
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Vomiting - "Severe"
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Headache- "Mild"
|
18 Participants
|
23 Participants
|
19 Participants
|
19 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Headache - "Severe"
|
3 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Light Headed/Dizzy - "Mild"
|
11 Participants
|
7 Participants
|
17 Participants
|
14 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Light Headed/Dizzy - "Severe"
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Opioid Antagonist Reported Side Effects: 4-Weeks Post Quit Date
Anxiety/Agitation - "Mild"
|
18 Participants
|
19 Participants
|
27 Participants
|
23 Participants
|
Adverse Events
Placebo
Serious events: 2 serious events
Other events: 92 other events
Deaths: 0 deaths
Naltrexone
Serious events: 2 serious events
Other events: 101 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=154 participants at risk
Participants receiving Placebo as part of the trial
|
Naltrexone
n=161 participants at risk
Participants receiving Naltrexone as part of the trial
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Brain Mass
|
0.00%
0/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
0.62%
1/161 • Number of events 1
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
Psychiatric disorders
Suicidal Ideation Remitting in 2 Days with Recurrence
|
0.00%
0/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
0.62%
1/161 • Number of events 1
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer
|
0.65%
1/154 • Number of events 1
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
0.00%
0/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Motor Vehicle Collision
|
0.65%
1/154 • Number of events 1
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
0.00%
0/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
Other adverse events
| Measure |
Placebo
n=154 participants at risk
Participants receiving Placebo as part of the trial
|
Naltrexone
n=161 participants at risk
Participants receiving Naltrexone as part of the trial
|
|---|---|---|
|
General disorders
Nausea
|
16.9%
26/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
32.3%
52/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Vomiting
|
3.2%
5/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
6.2%
10/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Headache
|
37.0%
57/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
41.6%
67/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Lightheaded or dizzy
|
24.0%
37/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
35.4%
57/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Flushed or warm
|
23.4%
36/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
28.6%
46/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Tiredness
|
59.1%
91/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
60.9%
98/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Agitation or anxiety
|
53.2%
82/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
47.2%
76/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
|
General disorders
Increased Sexual Desire
|
24.0%
37/154
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
28.0%
45/161
Number of participant at risk represent those assigned to either Naltrexone or Placebo condition (i.e. receiving treatment) - Placebo: n=154, Naltrexone: n=161
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place