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Lorcaserin in Combination With XR-Naltrexone for Relapse Prevention in Opioid Use Disorder

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ClinicalTrials.gov Identifier: NCT03169816
Recruitment Status : Completed
First Posted : May 30, 2017
Results First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Information provided by (Responsible Party):
Frances R Levin, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Opioid-use Disorder
Interventions Drug: Lorcaserin
Drug: Placebo
Enrollment 60
Recruitment Details  
Pre-assignment Details 60 patients were enrolled in the trial but of these 49 patients were randomized to one of the treatment arms.
Arm/Group Title Lorcaserin Placebo
Hide Arm/Group Description

10 mg capsule taken twice daily of lorcaserin

Lorcaserin: Lorcaserin 10mg, twice daily

a placebo comparator capsule taken twice daily

Placebo: Matched placebo for lorcaserin condition dosed twice daily

Period Title: Overall Study
Started 33 16
Completed 6 3
Not Completed 27 13
Arm/Group Title Lorcaserin Placebo Total
Hide Arm/Group Description

10 mg capsule taken twice daily of lorcaserin

Lorcaserin: Lorcaserin 10mg, twice daily

a placebo comparator capsule taken twice daily

Placebo: Matched placebo for lorcaserin condition dosed twice daily

Total of all reporting groups
Overall Number of Baseline Participants 33 16 49
Hide Baseline Analysis Population Description
Baseline analysis for the 49 randomized patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 33 participants 16 participants 49 participants
35.8  (9.9) 39.5  (12.6) 37.0  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
Female
8
  24.2%
3
  18.8%
11
  22.4%
Male
25
  75.8%
13
  81.3%
38
  77.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
Hispanic or Latino
7
  21.2%
2
  12.5%
9
  18.4%
Not Hispanic or Latino
26
  78.8%
14
  87.5%
40
  81.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants 16 participants 49 participants
American Indian or Alaska Native
0
   0.0%
1
   6.3%
1
   2.0%
Asian
0
   0.0%
1
   6.3%
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  15.2%
4
  25.0%
9
  18.4%
White
22
  66.7%
10
  62.5%
32
  65.3%
More than one race
3
   9.1%
0
   0.0%
3
   6.1%
Unknown or Not Reported
3
   9.1%
0
   0.0%
3
   6.1%
1.Primary Outcome
Title Proportion of Patients Successfully Inducted to Receive Naltrexone Injection
Hide Description proportion of individuals who were successfully inducted and received the first XR-naltrexone injection
Time Frame Study week 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lorcaserin Placebo
Hide Arm/Group Description:

10 mg capsule taken twice daily of lorcaserin

Lorcaserin: Lorcaserin 10mg, twice daily

a placebo comparator capsule taken twice daily

Placebo: Matched placebo for lorcaserin condition dosed twice daily

Overall Number of Participants Analyzed 33 16
Measure Type: Count of Participants
Unit of Measure: Participants
12
  36.4%
7
  43.8%
Time Frame During the 8 weeks of the trial or length of participant's participation.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lorcaserin Placebo
Hide Arm/Group Description

10 mg capsule taken twice daily of lorcaserin

Lorcaserin: Lorcaserin 10mg, twice daily

a placebo comparator capsule taken twice daily

Placebo: Matched placebo for lorcaserin condition dosed twice daily

All-Cause Mortality
Lorcaserin Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/33 (0.00%)      0/16 (0.00%)    
Hide Serious Adverse Events
Lorcaserin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/33 (6.06%)      0/16 (0.00%)    
General disorders     
Inpatient rehabilitation  [1]  2/33 (6.06%)  2 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Two participants voluntarily entered inpatient rehabilitation programs prior to completing the trial.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lorcaserin Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/33 (42.42%)      7/16 (43.75%)    
Gastrointestinal disorders     
GI Upset   4/33 (12.12%)  4 1/16 (6.25%)  1
Vomiting   3/33 (9.09%)  3 1/16 (6.25%)  1
Diarrhea   1/33 (3.03%)  1 1/16 (6.25%)  1
Hot flashes   2/33 (6.06%)  2 0/16 (0.00%)  0
Constipation   0/33 (0.00%)  0 1/16 (6.25%)  1
Nausea   0/33 (0.00%)  0 1/16 (6.25%)  1
GI Ulcer   0/33 (0.00%)  0 1/16 (6.25%)  1
General disorders     
insomnia   3/33 (9.09%)  3 3/16 (18.75%)  3
Anorexia   2/33 (6.06%)  2 2/16 (12.50%)  2
Chills   2/33 (6.06%)  2 0/16 (0.00%)  0
Precipitated Withdrawal   1/33 (3.03%)  1 1/16 (6.25%)  1
Blackout   0/33 (0.00%)  0 1/16 (6.25%)  1
Dehydration   1/33 (3.03%)  1 0/16 (0.00%)  0
Fatigue   0/33 (0.00%)  0 1/16 (6.25%)  1
Fainting   1/33 (3.03%)  1 0/16 (0.00%)  0
Gout   1/33 (3.03%)  1 0/16 (0.00%)  0
Headache   1/33 (3.03%)  1 0/16 (0.00%)  0
Head Sensation   1/33 (3.03%)  1 0/16 (0.00%)  0
Irritable   1/33 (3.03%)  1 0/16 (0.00%)  0
Leg Cramps   1/33 (3.03%)  1 0/16 (0.00%)  0
Loss of Libido   1/33 (3.03%)  1 0/16 (0.00%)  0
Sexual Dysfunction   1/33 (3.03%)  1 0/16 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Bachache   1/33 (3.03%)  1 0/16 (0.00%)  0
Muscle Aches   0/33 (0.00%)  0 1/16 (6.25%)  1
Psychiatric disorders     
Anxiety   3/33 (9.09%)  3 0/16 (0.00%)  0
Suicidal Ideation   1/33 (3.03%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Frances R Levin, MD
Organization: New York State Psychiatric Institute
Phone: 6467746137
EMail: frl2@columbia.edu
Layout table for additonal information
Responsible Party: Frances R Levin, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03169816    
Other Study ID Numbers: 7501
First Submitted: May 25, 2017
First Posted: May 30, 2017
Results First Submitted: August 25, 2020
Results First Posted: October 5, 2020
Last Update Posted: October 5, 2020