Stopping prescription opioid pain medications can be difficult due to withdrawal symptoms. This study will test if LUCEMYRA helps reduce withdrawal symptoms and helps more people reduce their opioid dose compared to placebo.
This randomized, double-blind, placebo-controlled pilot study will evaluate the safety and effectiveness of LUCEMYRA in the treatment of opioid withdrawal during an opioid taper in subjects with chronic non-cancer pain. Subjects will begin a planned 14-day complete taper of their pre-study opioid medications and will be randomly assigned (1:1) to either LUCEMYRA or matching placebo. Study drug will be administered through the opioid taper and for 5 days after the opioid taper is completed. Study drug will then be tapered over a 4-day period for a total of approximately 21 days exposure to study drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
Westview Clinical Research, LLC
Placentia, California, United States
Vitamed Research
Rancho Mirage, California, United States
Gold Coast Research, LLC
Plantation, Florida, United States
Number of Treatment Emergent AEs and SAEs
Time frame: Day 1 through Day 28
Number and Percent of Subjects Reporting TEAEs Resulting in Study Drug Discontinuation
Time frame: Day 1 through Day 28
Percentage of Subjects With Treatment-emergent Elevated Liver Function Tests
Time frame: Day 1 through Day 28
Percentage of Subjects Identified as Suicide Risk With Columbia Suicide Severity Rating Scale
The C-SSRS measures both suicidal ideation and suicidal behavior. The Screener contains "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide. A significant risk of suicide is defined as a "yes" in answer to: a) questions 4 or 5 on the suicidal ideation section, or b) any questions on any item in the suicidal behavior section. This must be reported as an SAE and followed up accordingly. Additionally, if a subject responds "yes" to any of the suicidal ideation questions 1 to 3, the Investigator should apply clinical judgment to determine the need for reporting as an AE or SAE and the need for any referral.
Time frame: Day 1 through Day 28
Change in Blood Pressure
Orthostatic vital signs were measured in-clinic only. When the subject is at home, only resting vital signs will be collected. Orthostatic vital signs will be measured first after the subject has been sitting for at least 5 minutes and then after the subject has been standing for at least 3 minutes. Resting vital signs only will be measured at home and will be measured after the subject has been sitting quietly for at least 5 minutes.
Time frame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Change in Pulse
Time frame: Baseline to Days 1, 2, 3, 7, 8, 14, 15, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
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Georgia Clinical Research, LLC
Lawrenceville, Georgia, United States
Injury Care Research
Boise, Idaho, United States
Global Scientific Innovations
Evansville, Indiana, United States
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Neuroscience Research Center, LLC
Overland Park, Kansas, United States
Otrimed Corporation (Otrimed Clinical Research Center)
Edgewood, Kentucky, United States
University of Rochester
Rochester, New York, United States
...and 2 more locations
Percentage of Subjects Who Successfully Complete Each Scheduled Dose Reduction and the Opioid Taper to Complete Opioid Discontinuation
Time frame: Day 1 through Day 28
Change in Clinical Opiate Withdrawal Scale (COWS)
The COWS is a clinician-administered instrument that rates 11 common opioid withdrawal signs and symptoms. These include: resting pulse rate; sweating; restlessness; pupil size; bone or joint aches; runny nose or tearing; gastrointestinal upset; tremor; yawning; anxiety or irritability; and gooseflesh skin. Lower total scores indicate a more positive clinical outcome. Score: 5-12 = mild; 13-24 = moderately severe; more than 36 = severe withdrawal. Scores range from a minimum of 0 to a maximum of 48.
Time frame: Day 1 (pre-1st dose) to Days 3, 8, 15, 22 and 28
Change in the Short Opiate Withdrawal Scale of Gossop (SOWS-G)
The SOWS-Gossop scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 10 items that are scored on a 4-point scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe (minimum score of 0, maximum score of 30). The overall score is the simple sum of the 10 item scores. Lower observed values in SOWS-Gossop scores indicate a more positive clinical outcome.
Time frame: Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Change in Subjective Opiate WIthdrawal Scale of Handelsman (SOWS-H)
The SOWS-H scale assesses subjective symptoms of opioid withdrawal. It is a subject-rated scale consisting of 19 items that are scored on a 5-point scale of 0 = not at all, 1 = a little, 2 = moderately, 3 = quite a bit, and 4 = extremely. The overall score is the simple sum of the 19 item scores. Lower observed values in SOWS-H scores indicate a more positive clinical outcome.
Time frame: Day 1 (pre-1st dose) to Days 1 (at bedtime), 2, 3, 4, 5, 6, 7, 8, 9, 10,11, 12,13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27 and 28
Modified Clinical Global Impression - Rater Version (MCGI-R) Average Score
MCGI-R includes 2 items: A 7-point scale that allows clinicians to rate the severity of a subject's opiate withdrawal symptoms. A 4-point scale that allows clinicians to rate the degree of a subject's side effects from study drug. SEVERITY OF ILLNESS: 1. = No at all ill 2. = Borderline ill 3. = Mildly ill 4. = Moderately ill 5. = Markedly ill 6. = Severely ill 7. = Among the most extremely ill subjects SIDE EFFECTS INDEX: 1. = None, study drug is producing no side effects 2. = Do not significantly interfere with subject's functioning 3. = Significantly interferes with subject's functioning 4. = Outweighs therapeutic effect
Time frame: Each scheduled evaluation (Study Visits 2, 3, 4, 5, EOS)
Modified Clinical Global Impression - Subject Version (MCGI-S)
Includes: A 7-point scale for subjects to rate the severity of opiate withdrawal symptoms. A 4-point scale for subjects to rate the degree of side effects from their study drug. SEVERITY OF OPIATE WITHDRAWAL: 1. = No opiate withdrawal symptoms 2. = On the border between no to mild opiate withdrawal symptoms 3. = Mild opiate withdrawal symptoms 4. = Moderate opiate withdrawal symptoms 5. = Marked opiate withdrawal symptoms 6. = Severe opiate withdrawal symptoms 7. = The most severe opiate withdrawal symptoms that I have ever had SIDE EFFECTS INDEX (Scale B): 1. = None. The study drug has no side effects 2. = The study drug has slight side effects, but it does NOT significantly interfere with my day to day activities 3. = The study drug has moderate side effects, and it DOES significantly interfere with my day to day activities 4. = The study drug has severe side effects, and these side effects are greater than the relief from opiate withdrawal symptoms that it provides
Time frame: Each scheduled evaluation (Day 1 through Day 28)
Time to Study Drug Discontinuation
Study day of participant discontinuation.
Time frame: Day 1 through Day 28
Number of Non-opioid Concomitant Medications for Withdrawal Symptoms Used by Study Day
Time frame: Day 1 through Day 28
Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Scale
The EQ-5D-5L is an instrument that evaluates preference for health status through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each of which are rated on 5 levels of severity. Each dimension ranges from a minimum of "0 - I have no problems or I am not" to a maximum of "5 - I am unable to or I am extremely". The dimensions are averaged together for a single score and the change in average score from baseline is recorded.
Time frame: Change from Baseline to EOS
Change in Short Form Health Survey (SF-36) Scale
The SF-36 consists of 36 questions that measure various aspects of physical and mental well-being. Precoded values are recorded for each question ranging from 0-100, with a high score defined as a more favorable health status. The items are then averaged together to create the 8 scale scores which are averaged together to create a scale. The final value reported is the average change in the averaged scale scores from baseline to end of study.
Time frame: Change from baseline to End of Study, up to 55 days
Change in Insomnia Severity Index (ISI)
The ISI is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. The dimensions evaluated are: severity of sleep onset, sleep maintenance and early morning awakening problems, sleep dissatisfaction, interference of sleep difficulties with daytime functioning, noticeability of sleep problems by others, and distress caused by the sleep difficulties. A 5-point Likert scale is used to rate each item on a scale 0 to 4 for each of the 7 items, yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
Time frame: Change from baseline to Days 15 and End of Study, up to 55 days
Change in Hospital Anxiety and Depression Scale (HADS)
The HADS is a self-reported screening tool for anxiety and depression in nonpsychiatric clinical populations. Responses are based on the relative frequency of symptoms over the preceding week. The scale consists of 14 items, with a subscale of 7 questions for anxiety and 7 questions for depression. Patients rate each item in the subscales on a 4-point scale ranging from 0 (absence) to 3 (extreme presence). Possible scores range from 0 to 21 for each subscale. An analysis of scores on the 2 subscales supported the differentiation of each mood state into 4 ranges: non-cases (scores 0 to 7), mild cases (scores 8 to 10), moderate cases (scores 11 to 15), and severe cases (scores 16 or higher), with lower values being favorable. The subscales are then combined for a total score ranging from 0 to 42. Higher scores indicate greater levels of anxiety or depression. The value reported is the average change from baseline to End of Study.
Time frame: Change from End of Study to Baseline, up to 55 days
Change in Average Chronic Pain as Measured by the Numeric Rating Scale (NRS)
A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Baseline through Follow-up (assessed daily)
Change in Average Overall Pain as Measured by the Numeric Rating Scale (NRS)
The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Day 1 through Day 28 (assessed daily)
Change in Worst Chronic Pain as Measured by the Numeric Rating Scale (NRS)
The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Baseline through Day 51 (assessed daily)
Change in Worst Overall Pain as Measured by the Numeric Rating Scale (NRS)
The NRS of pain intensity is a unidimensional, segmented numeric version of the visual analog scale. A subject selects a whole number (0 to 10) that best indicates the intensity of his/her pain. The format consists of a horizontal line which is anchored by terms defining pain levels where 0 represents no pain and 10 represents worst pain imaginable.
Time frame: Day 1 through Day 28 (assessed daily)
Change in Daily Opioid Dose Expressed as Morphine Equivalent Dose (MED)
Time frame: Baseline through Day 28
Change in Daily Opioid Dose as a Percentage of the Baseline MED
Time frame: Baseline through Day 28