Assessing a Clinically-meaningful Opioid Withdrawal Phenotype
Purpose
Evaluate individual differences in the expression of opioid withdrawal symptoms in persons with opioid use disorder (OUD) while completing a clinically-indicated medication taper.
Conditions
- Opioid Withdrawal
- Opioid Use Disorder
- Opioid Craving
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 years - 65 year old - Opioid-positive urine sample - Current opioid use disorder with evidence of physical dependence - Interest in undergoing opioid taper
Exclusion Criteria
- Evidence of physical dependence on alcohol or benzodiazepines that requires medical intervention - Being pregnant or breastfeeding - Enrolled in methadone or buprenorphine maintenance treatment - Clinically significant hypotension (<90/60mmHg) or bradycardia (<45bpm) - History of myocardial infarction - Subjects who are positive for hepatitis B surface antigen and/or hepatitis C antibody with liver function tests outside the normal range (persons with a positive hepatitis C antibody and normal liver functions tests are NOT excluded from the study) - Significant mental health or physical disorder, or life circumstances, that is expected to interfere with study participation
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
- Masking Description
- The order of medication pre-treatment during the two Naloxone Challenges will be blinded to participants and the investigator.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Within-subject design |
All participants will undergo the same study design, which includes morphine stabilization (days 1-5), two naloxone challenges (scheduled during morphine stabilization), lofexidine-assisted taper (days 6-10), and transition to aftercare (day 11). |
|
Recruiting Locations
Baltimore, Maryland 21201
More Details
- Status
- Recruiting
- Sponsor
- University of Maryland, Baltimore
Detailed Description
Individuals who have opioid use disorder and are interested in being tapered off of opioids will be admitted to a residential research unit for an 11-day period. All participants will be maintained on morphine for 5 days. During this period participants will complete 2 sessions (on two different days) wherein participants will receive an intramuscular injection of naloxone to precipitate a short withdrawal syndrome. Participants will take a capsule prior to both sessions that will contain either placebo or the opioid withdrawal medication lofexidine. Beginning on day 6 participants will be tapered off of morphine using lofexidine (as clinically indicated). At the end of the study all participants will be able to transition to buprenorphine maintenance or receive oral naltrexone and an injection of Vivitrol (extended release naltrexone), consistent with standard of care practices. Investigators will collect a variety of biological samples and questionnaire ratings during the study and primary outcomes will be measures of withdrawal collected throughout the study. Investigators will use these data to learn more about why individuals express opioid withdrawal symptoms differently, which will help inform how to change current treatment practices to be more effective for persons with OUD.