Opioid-use Disorder
Conditions
Brief summary
This study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into our program of outpatient detoxification and naltrexone induction followed by a relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or placebo (N = 20) with weekly therapy.
Detailed description
The study proposes to recruit patients with Opioid Use Disorder (OUD) seeking treatment into our program of outpatient detoxification and naltrexone induction followed by a relapse-prevention treatment with Extended release-naltrexone (XR-NTX) . Eligible participants will be randomly assigned to adjunctive treatment with lorcaserin (N = 40), or placebo (N = 20) with weekly therapy. Lorcaserin or placebo 10 mg bid will be started on Day 1 of the study to address acute withdrawal, then maintained over the next 5 weeks, and stopped after the second XR-naltrexone is administered. Patients will be seen twice weekly for monitoring and offered two injections of naltrexone; at the end of oral naltrexone induction (end of week 1) and four weeks later (week 5). The primary outcome measures will be the proportion of patients successfully inducted onto XR-naltrexone.
Interventions
DRUGLorcaserin
Lorcaserin 10mg, twice daily
DRUGPlacebo
Matched placebo for lorcaserin condition dosed twice daily
Sponsors
New York State Psychiatric Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 1\. Individuals between the ages of 18-60 2\. Meets DSM-5 criteria of current opioid use disorder present for at least six months, supported by a positive urine for opioids 3\. Seeking treatment for opioid use disorder 4\. Capable of giving informed consent and complying with study procedures 5\. Not underweight; defined as BMI≥18.5
Exclusion criteria
1. Lifetime history of DSM-5 diagnosis of schizophrenia, schizoaffective disorder, or bipolar disorder 2. Current DSM-5 criteria for any other psychiatric disorder that in the investigator's judgment is unstable, would be disrupted by the study medication, or is likely to require pharmacotherapy or psychotherapy during the study period. Concurrent treatment with other psychotropic medication is exclusionary. 3. Individuals who meet DSM-5 criteria for any substance use disorders - severe, other than opioid and nicotine use disorder. Physiological dependence on alcohol or sedative-hypnotics is exclusionary. 4. A recent history of binge-use of alcohol or sedative-hypnotics (using large amounts in a short time to severe intoxication or blackouts). 5. Pregnancy, lactation, or failure to use adequate contraceptive method in female patients who are currently engaging in sexual activity with men. 6. Unstable medical conditions, such as AIDS, cancer, uncontrolled hypertension (blood pressure \> 140/90), uncontrolled diabetes, pulmonary hypertension or heart disease. 7. Legally mandated to participate in a substance use disorder treatment program. 8. Current or recent history of significant violent or suicidal behavior, risk for suicide or homicide 9. Currently meets DSM-5 diagnosis for an eating disorder with low body weight (BMI \<20) 10. History of accidental opioid overdose in the last three years or any other significant history of overdose following detoxification within past 10 years defined as an episode of opioid-induced unconsciousness, whether or not medical treatment was sought or received. 11. Elevated liver function tests (AST and ALT \> 3 times the upper limit of normal) or impaired renal function (GFR\<60 ml/min) 12. Known history of allergy, intolerance, or hypersensitivity to lorcaserin, naltrexone or any other study medications 13. Concurrent use of migraine medications containing ergotamine (Cafergot, Ergomar) or dihydroergotamine (Migranal), 5HT2B receptor agonists like cabergoline, or medications metabolized by CYP2D6 (thioridazine, tamoxifen, metoprolol, aripiprazole, codeine)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients Successfully Inducted to Receive Naltrexone Injection | Study week 1 | proportion of individuals who were successfully inducted and received the first XR-naltrexone injection |
Countries
United States
Participant flow
Pre-assignment details
60 patients were enrolled in the trial but of these 49 patients were randomized to one of the treatment arms.
Participants by arm
| Arm | Count |
|---|---|
| Lorcaserin 10 mg capsule taken twice daily of lorcaserin
Lorcaserin: Lorcaserin 10mg, twice daily | 33 |
| Placebo a placebo comparator capsule taken twice daily
Placebo: Matched placebo for lorcaserin condition dosed twice daily | 16 |
| Total | 49 |
Baseline characteristics
| Characteristic | Placebo | Total | Lorcaserin |
|---|---|---|---|
| Age, Continuous | 39.5 years STANDARD_DEVIATION 12.6 | 37.0 years STANDARD_DEVIATION 10.9 | 35.8 years STANDARD_DEVIATION 9.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 9 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants | 40 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) White | 10 Participants | 32 Participants | 22 Participants |
| Sex: Female, Male Female | 3 Participants | 11 Participants | 8 Participants |
| Sex: Female, Male Male | 13 Participants | 38 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 16 |
| other Total, other adverse events | 14 / 33 | 7 / 16 |
| serious Total, serious adverse events | 2 / 33 | 0 / 16 |
Outcome results
Primary
Proportion of Patients Successfully Inducted to Receive Naltrexone Injection
proportion of individuals who were successfully inducted and received the first XR-naltrexone injection
Time frame: Study week 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lorcaserin | Proportion of Patients Successfully Inducted to Receive Naltrexone Injection | 12 Participants |
| Placebo | Proportion of Patients Successfully Inducted to Receive Naltrexone Injection | 7 Participants |