Opioid Withdrawal Clinical Trial
Official title:
A Phase 1b/2 Randomized, Double-Blind, Placebo-Controlled, Ascending-Dose Study of BXCL501 to Treat Symptoms of Acute Opioid Withdrawal in Patients With Opioid Use Disorder Who Are Physically Dependent on Opioids
Verified date | October 2023 |
Source | BioXcel Therapeutics Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase 1b/2 inpatient study assessed the safety, pharmacokinetics, and early signs of efficacy of escalating doses of BXCL501 versus placebo following discontinuation of morphine maintenance. The opioid (morphine) maintenance phase (Phase 1b) included Days 1-5; the randomized BXCL501/placebo phase (Phase 2) included Days 6-12. The randomized phase was followed by 2 sequential days, Days 13 and 14, utilizing treatment of BXCL501-placebo sublingual films and morphine-placebo capsules for all subjects who remained in the study.
Status | Completed |
Enrollment | 225 |
Est. completion date | February 18, 2021 |
Est. primary completion date | February 18, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria 1. Male and female subjects who are 18 years of age to less than 65 years of age. 2. Meets criteria for moderate to severe opioid use disorder as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) with physiological dependence as evidenced by a Clinical Opiate Withdrawal (COWS) score of >5 or a positive naloxone challenge upon admission on Day 1. 3. Subjects who can read, understand, and provide written informed consent. Women of childbearing potential must have a negative pregnancy test and agree to be abstinent or use an acceptable method of contraception for the duration of the study. Exclusion Criteria 1. Positive urine pregnancy test at screening or when tested or currently breast feeding. 2. Clinically significant history of cardiac disease, screening and baseline heart rate of <55 beats per minutes or systolic blood pressure <110 mmHg or diastolic blood pressure <70 mmHg. 3. History or presence of a significant medical disease or disorder which, in the opinion of the investigator, increases the risk or may confound the interpretation of study measures, as confirmed by screening laboratory results. 4. Hepatic dysfunction (marked by ascites, or bilirubin >10% above the upper limit of normal [ULN] or liver function tests >3 x ULN) at the screening visit. 5. Acute active Hepatitis B or C as evidenced by positive serology and aspartate aminotransferase (AST)/alanine aminotransferase (ALT) >2 x ULN. 6. Clinically significant abnormal ECG findings such as second- or third-degree heart block, uncontrolled arrhythmia, or QTcF (Fridericia correction formula) interval >450 msec for males, and >470 msec for females at screening or prior to dosing. 7. Any psychiatric disorder that would compromise ability to complete study requirements. 8. Currently meets DSM-5 criteria for substance abuse disorder, moderate or severe for any substance other than opioids, caffeine, or nicotine and/or current physical dependence on drugs that pose risk of withdrawal that requires medical management such as alcohol or benzodiazepines. 9. History of suicidal behavior within the last 1 year prior to screening. 10. Participation in a clinical trial of a non-FDA-approved pharmacological agent within 30 days prior to screening. 11. Use of any excluded medication at screening or anticipated/required use during the study period. 12. Subjects with a history of intolerance to morphine. 13. Any finding that, in the view of the principal investigator, would compromise the subject's ability to fulfill the protocol visit schedule or visit requirements. |
Country | Name | City | State |
---|---|---|---|
United States | BioXcel Clinical Research Site | Marlton | New Jersey |
United States | BioXcel Clinical Research Site | Miami Lakes | Florida |
United States | BioXcel Clinical Research Site | New York | New York |
Lead Sponsor | Collaborator |
---|---|
BioXcel Therapeutics Inc | Cognitive Research Corporation |
United States,
Jones JD, Rajachandran L, Yocca F, Risinger R, De Vivo M, Sabados J, Levin FR, Comer SD. Sublingual dexmedetomidine (BXCL501) reduces opioid withdrawal symptoms: findings from a multi-site, phase 1b/2, randomized, double-blind, placebo-controlled trial. Am J Drug Alcohol Abuse. 2023 Jan 2;49(1):109-122. doi: 10.1080/00952990.2022.2144743. Epub 2023 Jan 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peak SOWS Scores at Baseline and Over Time | Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids. Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms. | Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose | |
Secondary | Peak COWS Score at Baseline and Over Time | Clinical Opiate Withdrawal Scale (COWS): The COWS scale is a validated, 11-item questionnaire designed to quantify withdrawal symptoms. Symptoms evaluated 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. COWS total scores range from 0 to 48, with 5 to 12 indicating mild symptoms, 13 to 24 indicating moderate symptoms, 25 to 36 indicating moderately severe symptoms, and greater than 36 indicating severe symptoms. | Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose | |
Secondary | Average COWS Scores at Baseline and Over Time | Clinical Opiate Withdrawal Scale (COWS): The COWs scale is a validated, 11-item questionnaire designed to quantify withdrawal symptoms. Symptoms evaluated 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. COWS total scores range from 0 to 48, with 5 to 12 indicating mild symptoms, 13 to 24 indicating moderate symptoms, 25 to 36 indicating moderately severe symptoms, and greater than 36 indicating severe symptoms. | Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose | |
Secondary | Average SOWS at Baseline and Over Time | Short Opiate Withdrawal Scale (SOWS)-Gossop: The SOWs scale is a validated 10-item patient-reported scale designed to measure the symptoms of withdrawal in subjects who are dependent on opioids.5 Each of the 10 items represents a symptom: "feeling sick," "stomach cramps," "muscle spasms/twitching," "feeling of coldness," "heart pounding," "muscular tension," "aches and pains," "yawning," "runny eyes," and "insomnia/problems sleeping." Scores on the SOWS-Gossop can range from 0 to 30, with higher scores indicating greater severity of withdrawal symptoms. | Baseline (pre-dose day 6) and at days 6, 7, 8, 9, 10, 11, 12, 13, and 14 post-dose | |
Secondary | Time to Drop-out After Discontinuation of Opioid Maintenance Phase | Time to drop-out during double-blind treatment phase after discontinuation of opioid maintenance Phase. | Day 6 through Day 14 | |
Secondary | Number and Percentage of Subject Drop-out After Discontinuation of Opioid Maintenance Phase Maintenance Within Each Treatment Group | Number and Percentage of Subject Drop-out after Discontinuation of Opioid Maintenance Phase Within Each Treatment Group Between Days 6-14. | Day 6 through Day 14 | |
Secondary | Total ACES Total Score Over Time - 2 hr. Post-First Dose | Overall Agitation-Calmness Evaluation Scale (ACES): The ACES scale is a single-item measure rating overall agitation and sedation, ranging from 1 (marked agitation) to 9 (unarousable). This outcome measures the total ACES total score over time at 2 hours, post-first dose. | Post-Dose Day 6 to Day 12 |
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