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Impact of Lofexidine on Stress, Craving and Opioid Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718065
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Medical University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Opiate Dependence Drug: Lofexidine Drug: Placebo Phase 2

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 3 times that week for urine drug testing. If all 3 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) 2 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Lofexidine on Stress, Craving and Opioid Use
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : April 1, 2024

Resource links provided by the National Library of Medicine


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.
Drug: Lofexidine
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 Name: Lucemyra

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.
Drug: Lofexidine
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 Name: Lucemyra

Placebo Comparator: Placebo Men
Men will receive matching placebo for five weeks.
Drug: Placebo
Placebo comparator.

Placebo Comparator: Placebo Women
Women will receive matching placebo for five weeks.
Drug: Placebo
Placebo comparator.




Primary Outcome Measures :
  1. Drug Cue+ Stressor Induced Craving [ Time Frame: Immediately following social stress and scripted imagery tasks ]
    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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. 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) within the last 60 days.
  3. On a stable dose of daily buprenorphine or methadone for at least 4 weeks.
  4. Age 18-50.
  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 orbipolar 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718065


Contacts
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Contact: Constance Guille, MD 843-792-6489 guille@musc.edu
Contact: Lisa Nunn, MS 843-792-0476 jenkinli@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29403
Contact: Lisa Nunn, MS    843-792-0476    jenkinli@musc.edu   
Contact: Connie Guille, MD    843-792-6489    guille@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
National Institutes of Health (NIH)
National Institute on Drug Abuse (NIDA)
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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03718065    
Other Study ID Numbers: Pro00081381
2U54DA016511-16 ( U.S. NIH Grant/Contract )
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Lofexidine
Antihypertensive Agents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action