Overview

Impact of Lofexidine on Stress, Craving and Opioid Use

Status:
Recruiting

Trial end date:
2023-07-31

Target enrollment:
0

Participant gender:
All

Summary

Individuals with opioid use disorder who are stabilized on buprenorphine or methadone will be randomly assigned to receive placebo or lofexidine for 5 weeks. At the end of five weeks, they will complete a human laboratory stress task and scripted opioid imagery task. Throughout the study a CREMA app (Cue Reactivity Ecological Momentary Assessment) will be used to monitor stress, craving and use in the natural environment.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Medical University of South Carolina

Collaborators:

National Institute on Drug Abuse (NIDA)
National Institutes of Health (NIH)

Treatments:

Clonidine
Lofexidine

Criteria

Inclusion Criteria

1. Able to provide informed consent and function at an intellectual level sufficient to
allow accurate completion of all assessment instruments.

2. Meet DSM-5 criteria for opioid use disorder (within the past three months). While
individuals may also meet criteria for mild use disorders of other substances, they
must identify opioids as their primary substance of abuse and must not meet criteria
for any other moderate or severe substance use disorder (except tobacco, caffeine, or
marijuana) within the last 60 days.

3. On a stable dose of daily buprenorphine or methadone for at least 2 weeks.

4. Age 18-65.

5. Women of childbearing potential must agree to use an effective means of birth control.

6. Consent to remain abstinent from opioids during the 1-week baseline assessment period.

7. Must consent to random assignment.

Exclusion Criteria

1. Women who are pregnant, nursing or of childbearing potential and not practicing an
effective means of birth control.

2. Evidence or history of major medical illnesses, including liver diseases, abnormal
vaginal bleeding, suspected or known malignancy, thrombophlebitis, deep vein
thrombosis, pulmonary embolus, clotting or bleeding disorders, heart disease,
insulin-dependent diabetes, history of stroke or other medical conditions that the
investigator deems as contraindicated for the individual to be in the study.

3. History of or current psychotic disorder or bipolar I affective disorder.

4. Current suicidal or homicidal ideation/risk.

5. Taking medications known to act on adrenergic systems (B-blockers; alpha agonists or
antagonists)

6. Hypotensive individuals with a sitting blood pressure of < 90/50

7. QTc interval of >440 in males and > 460 in females as the combination of lofexidine
plus buprenorphine may increase the QTc interval.

8. Known allergy to lofexidine

9. Unable to comply with study procedures or pose threat to study staff.