Facilitating Rapid Naltrexone Initiation

This study combines a nonopioid detoxification; a naltrexone titration schedule that allows
for pushing the dose rapidly while monitoring closely to ensure tolerability; and infusions
integrated into the treatment in such a way as to potentially ameliorate spontaneous and
precipitated withdrawal. The first part of the treatment trial involves receiving inpatient
treatment for up to 5 days. Following week 1, participants will meet with staff twice weekly
and receive 12 weeks of mindfulness based relapse prevention and motivational interviewing
sessions.

Inclusion Criteria:

1. DSM-5 criteria of current opioid use disorder present for at least six months,
supported by a positive urine for opioids or a positive naloxone challenge test (MINI,
psychiatric exam)

2. Aged 18 to 60 years (history)

3. In otherwise good health based on complete medical history, physical examination,
vital signs measurement, ECG, and laboratory tests (hematology, blood chemistry,
urinalysis) within normal ranges

4. Able to give written informed consent to participate in the study (psychiatric
evaluation)

5. Interested in maintenance treatment with extended-release naltrexone

Exclusion Criteria:

1. Physiologically dependent on alcohol or sedative-hypnotics with impending withdrawal
requiring medical management. (psych eval, MINI)

2. Methadone maintenance treatment or regular use of illicit methadone (>30 mg per week);
urine toxicology positive for methadone at admission (psych eval, urine tox)

3. Buprenorphine maintenance treatment or regular use of buprenorphine (>16 mg per week);
urine toxicology positive for buprenorphine at admission (psych eval, urine tox)

4. Active, or past, psychiatric disorder which might interfere with participation or make
participation hazardous, including DSM-V organic mental disorder, psychotic disorder,
or bipolar disorder with mania (psych eval, MINI)

5. Significant current suicidal risk or a suicide attempt within the past year (psych
eval)

6. On psychotropic or other medications that may interact adversely with study
medications, or whose effect might be disrupted by study medications (psych/med eval,
MINI)

7. Positive serum pregnancy test, lactation, or unwillingness to use a satisfactory
method of birth control (med eval, bloodwork)

8. Uncontrolled neurological, cardiovascular, renal, and hepatic diseases, active
tuberculosis, AIDS, or any other disorder that might make administration of study
medications hazardous (med eval)

9. Acute hepatitis with SGOT or SGPT > 3 times the upper end of the laboratory normal
range (bloodwork)

10. Concurrent participation in another treatment study or another substance abuse program
with the exception of a self-help group (psych eval)

11. History of allergy or sensitivity to any study medication (med eval)

12. Ongoing chronic pain that may require opioid management, or for which surgery is
indicated (med eval)

13. History of inability to tolerate study medications (psych eval)

14. History of ketamine use disorder (psych eval, MINI)

15. Active major depressive disorder (psych eval, MINI)