Clinical Trials of Multivalent Opioid Vaccine Components

Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.

Males and females aged 18 to 59 years.

Females must be non-pregnant, non-lactating and either be of non-childbearing potential (i.e. sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of childbearing potential but practicing a medically acceptable method of birth control

Meets current DSM 5 criteria for moderate-severe Psychiatric OUD, physical dependence on opioids, and current use of Examination opioids will be in amounts and/or frequencies that meet or exceed those used in the study (3-4 tablets of a prescription opioid medication per day or 1-2 bags of heroin and/or fentanyl per day). Participants may meet criteria for other behavioral disorders (e.g. gambling) or substance use disorders (cocaine or marijuana), but cannot be physically dependent on drugs that pose risk of withdrawal that requires medical management such as alcohol or benzodiazepines. Participant must self-identify their opioid of choice as being other than oxycodone, oxymorphone, hydrocodone, and hydromorphone (e.g., a heroin and/or fentanyl user). In addition, we will only include individuals who have prior experience with intranasal opioid use. Only participants with a minimum use of 1-2 bags of heroin and/or fentanyl per day and a maximum of 20 bags of heroin/fentanyl per day will be enrolled. The lower limit ensures that participants are physically dependent on opioids and are able to tolerate the proposed morphine maintenance regimen. The upper limit is consistent with our current experience in recruiting this population (where use of 30-50 bags/day is commonly reported because of the shorter duration of psychoactive effects produced by fentanyl compared to heroin).