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Impact of Lofexidine on Stress, Craving and Opioid Use

Primary Purpose

Opioid-use Disorder, Opiate Dependence

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lofexidine
Placebo
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South CarolinaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

Lofexidine Men

Lofexidine Women

Placebo Men

Placebo Women

Arm Description

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.

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.

Men will receive matching placebo for five weeks.

Women will receive matching placebo for five weeks.

Outcomes

Primary Outcome Measures

Drug Cue+ Stressor Induced Craving
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.
Drug Cue+ Stressor Induced Stress Response
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.

Secondary Outcome Measures

Full Information

First Posted
October 23, 2018
Last Updated
July 13, 2023
Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT03718065
Brief Title
Impact of Lofexidine on Stress, Craving and Opioid Use
Official Title
Impact of Lofexidine on Stress, Craving and Opioid Use
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institutes of Health (NIH), National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opiate Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
136 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lofexidine Men
Arm Type
Experimental
Arm Description
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.
Arm Title
Lofexidine Women
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Men
Arm Type
Placebo Comparator
Arm Description
Men will receive matching placebo for five weeks.
Arm Title
Placebo Women
Arm Type
Placebo Comparator
Arm Description
Women will receive matching placebo for five weeks.
Intervention Type
Drug
Intervention Name(s)
Lofexidine
Other Intervention Name(s)
Lucemyra
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator.
Primary Outcome Measure Information:
Title
Drug Cue+ Stressor Induced Craving
Description
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.
Time Frame
Immediately following social stress and scripted imagery tasks
Title
Drug Cue+ Stressor Induced Stress Response
Description
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.
Time Frame
Immediately following social stress and scripted imagery tasks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Constance Guille, MD
Phone
843-792-6489
Email
guille@musc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Nunn, MS
Phone
843-792-0476
Email
jenkinli@musc.edu
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Nunn, MS
Phone
843-792-0476
Email
jenkinli@musc.edu
First Name & Middle Initial & Last Name & Degree
Connie Guille, MD
Phone
843-792-6489
Email
guille@musc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34737091
Citation
Guille C, King C, Ramakrishnan V, Baker N, Cortese B, Nunn L, Rogers T, McRae-Clark A, Brady K. The impact of lofexidine on stress-related opioid craving and relapse: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2021 Dec;111:106616. doi: 10.1016/j.cct.2021.106616. Epub 2021 Nov 2.
Results Reference
derived

Learn more about this trial

Impact of Lofexidine on Stress, Craving and Opioid Use

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