Trial Outcomes & Findings for Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder (NCT NCT03169816)
NCT ID: NCT03169816
Last Updated: 2020-10-05
Results Overview
proportion of individuals who were successfully inducted and received the first XR-naltrexone injection
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Study week 1
Results posted on
2020-10-05
Participant Flow
60 patients were enrolled in the trial but of these 49 patients were randomized to one of the treatment arms.
Participant milestones
| Measure |
Lorcaserin
10 mg capsule taken twice daily of lorcaserin
Lorcaserin: Lorcaserin 10mg, twice daily
|
Placebo
a placebo comparator capsule taken twice daily
Placebo: Matched placebo for lorcaserin condition dosed twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
16
|
|
Overall Study
COMPLETED
|
6
|
3
|
|
Overall Study
NOT COMPLETED
|
27
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Lorcaserin
n=33 Participants
10 mg capsule taken twice daily of lorcaserin
Lorcaserin: Lorcaserin 10mg, twice daily
|
Placebo
n=16 Participants
a placebo comparator capsule taken twice daily
Placebo: Matched placebo for lorcaserin condition dosed twice daily
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
37.0 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
40 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study week 1proportion of individuals who were successfully inducted and received the first XR-naltrexone injection
Outcome measures
| Measure |
Lorcaserin
n=33 Participants
10 mg capsule taken twice daily of lorcaserin
Lorcaserin: Lorcaserin 10mg, twice daily
|
Placebo
n=16 Participants
a placebo comparator capsule taken twice daily
Placebo: Matched placebo for lorcaserin condition dosed twice daily
|
|---|---|---|
|
Proportion of Patients Successfully Inducted to Receive Naltrexone Injection
|
12 Participants
|
7 Participants
|
Adverse Events
Lorcaserin
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lorcaserin
n=33 participants at risk
10 mg capsule taken twice daily of lorcaserin
Lorcaserin: Lorcaserin 10mg, twice daily
|
Placebo
n=16 participants at risk
a placebo comparator capsule taken twice daily
Placebo: Matched placebo for lorcaserin condition dosed twice daily
|
|---|---|---|
|
General disorders
Inpatient rehabilitation
|
6.1%
2/33 • Number of events 2 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
Other adverse events
| Measure |
Lorcaserin
n=33 participants at risk
10 mg capsule taken twice daily of lorcaserin
Lorcaserin: Lorcaserin 10mg, twice daily
|
Placebo
n=16 participants at risk
a placebo comparator capsule taken twice daily
Placebo: Matched placebo for lorcaserin condition dosed twice daily
|
|---|---|---|
|
General disorders
insomnia
|
9.1%
3/33 • Number of events 3 • During the 8 weeks of the trial or length of participant's participation.
|
18.8%
3/16 • Number of events 3 • During the 8 weeks of the trial or length of participant's participation.
|
|
Gastrointestinal disorders
GI Upset
|
12.1%
4/33 • Number of events 4 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Anorexia
|
6.1%
2/33 • Number of events 2 • During the 8 weeks of the trial or length of participant's participation.
|
12.5%
2/16 • Number of events 2 • During the 8 weeks of the trial or length of participant's participation.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
3/33 • Number of events 3 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
Psychiatric disorders
Anxiety
|
9.1%
3/33 • Number of events 3 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Chills
|
6.1%
2/33 • Number of events 2 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
Gastrointestinal disorders
Diarrhea
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
Gastrointestinal disorders
Hot flashes
|
6.1%
2/33 • Number of events 2 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Precipitated Withdrawal
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
Musculoskeletal and connective tissue disorders
Bachache
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Blackout
|
0.00%
0/33 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/33 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Dehydration
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Fatigue
|
0.00%
0/33 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Fainting
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Gout
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Headache
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Head Sensation
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Irritable
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Leg Cramps
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Loss of Libido
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
Musculoskeletal and connective tissue disorders
Muscle Aches
|
0.00%
0/33 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/33 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
|
General disorders
Sexual Dysfunction
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
Psychiatric disorders
Suicidal Ideation
|
3.0%
1/33 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
0.00%
0/16 • During the 8 weeks of the trial or length of participant's participation.
|
|
Gastrointestinal disorders
GI Ulcer
|
0.00%
0/33 • During the 8 weeks of the trial or length of participant's participation.
|
6.2%
1/16 • Number of events 1 • During the 8 weeks of the trial or length of participant's participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place