- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03718065
Impact of Lofexidine on Stress, Craving and Opioid Use
April 5, 2024 updated by: Medical University of South Carolina
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants will complete a screening visit to determine study eligibility.
During the first week, participants will be asked to abstain from opioid use other than buprenorphine.
Participants will come to the clinic 2 times that week for urine drug testing.
If all 2 tests are negative, participants will be randomly assigned to take either lofexidine or placebo (inactive medication) two to three times a day for 5 weeks.
During this time, participants will upload videos of themselves taking their medication.
They will come to the clinic 3 times a week for urine drug screens and to have their vital signs measured.
They will also participate in "CREMA" sessions (Cue Reactivity Ecologic Momentary Assessment) 3 times a day.
These sessions include looking at stressful and neutral pictures and rating stress and craving.
At the end of five weeks, participants will return to the clinic and participate in a stress task and a scripted opioid imagery task the following day.
For the next five days, participants will taper their medication dose.
During this time they will continue to come to clinic to have their vital signs measured and complete a follow-up visit.
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Constance Guille, MD
- Phone Number: 843-792-6489
- Email: guille@musc.edu
Study Contact Backup
- Name: Lisa Nunn, MS
- Phone Number: 843-792-0476
- Email: jenkinli@musc.edu
Study Locations
-
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South Carolina
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Charleston, South Carolina, United States, 29403
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria
- Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- 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.
- On a stable dose of daily buprenorphine or methadone for at least 2 weeks.
- Age 18-65.
- Women of childbearing potential must agree to use an effective means of birth control.
- Consent to remain abstinent from opioids during the 1-week baseline assessment period.
- Must consent to random assignment.
Exclusion Criteria
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- 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.
- History of or current psychotic disorder or bipolar I affective disorder.
- Current suicidal or homicidal ideation/risk.
- Taking medications known to act on adrenergic systems (B-blockers; alpha agonists or antagonists)
- Hypotensive individuals with a sitting blood pressure of < 90/50
- QTc interval of >440 in males and > 460 in females as the combination of lofexidine plus buprenorphine may increase the QTc interval.
- Known allergy to lofexidine
- Unable to comply with study procedures or pose threat to study staff.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lofexidine Men
Men will receive lofexidine (Lucemyra) for 5 weeks.
Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
|
Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal.
It is taken by mouth.
It is an α2A adrenergic receptor agonist.
Other Names:
|
Experimental: Lofexidine Women
Women will receive lofexidine (Lucemyra) for 5 weeks.
Titration schedule is as follows: 0.36 mg on the first two evenings, 0.36 mg in the morning and evening on days 3 and 4; 0.36 mg in the morning, afternoon, and at bedtime on days 5 and 6; 0.36 mg in the morning and afternoon and 0.72 mg at bedtime on days 7 and 8; 0.36 mg in the morning and 0.72 mg in the afternoon and at bedtime on days 9 and 10, and 0.72 mg in the morning, afternoon and at bedtime on Day 11 and throughout the rest of the study.
|
Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal.
It is taken by mouth.
It is an α2A adrenergic receptor agonist.
Other Names:
|
Placebo Comparator: Placebo Men
Men will receive matching placebo for five weeks.
|
Placebo comparator.
|
Placebo Comparator: Placebo Women
Women will receive matching placebo for five weeks.
|
Placebo comparator.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drug Cue+ Stressor Induced Craving
Time Frame: Immediately following social stress and scripted imagery tasks
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Participants will rate craving on a 0 to 7 Likert scale with 0 indicate "Strongly disagree" that they crave and 10 indicating "strongly agree" that they crave so that higher scores indicate more craving.
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Immediately following social stress and scripted imagery tasks
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Drug Cue+ Stressor Induced Stress Response
Time Frame: Immediately following social stress and scripted imagery tasks
|
Participants will rate stress on a 0 to 4 Likert scale with 0 indicate "not at all" and 10 indicating "extremely" so that higher scores indicate a more robust stress response.
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Immediately following social stress and scripted imagery tasks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 26, 2019
Primary Completion (Actual)
January 30, 2024
Study Completion (Actual)
January 30, 2024
Study Registration Dates
First Submitted
October 23, 2018
First Submitted That Met QC Criteria
October 23, 2018
First Posted (Actual)
October 24, 2018
Study Record Updates
Last Update Posted (Actual)
April 8, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Substance-Related Disorders
- Narcotic-Related Disorders
- Opioid-Related Disorders
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Peripheral Nervous System Agents
- Sensory System Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Narcotic Antagonists
- Lofexidine
Other Study ID Numbers
- Pro00081381
- 2U54DA016511-16 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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