Clinical Trial Search

Primary: Change in Objective Opioid Withdrawal Score (OOWS) From Baseline (Prevention of Opioid Withdrawal) — 3.6; 3.6 units on a scale — p=0.87

Primary: Participant Acceptability of the Interventions — 1; 0 Participants

Primary: Area Under the Curve (AUC) in COWS Total Score on Days 1 to 5 Inclusive — 4.2; 3.4 Average COWS score * hours

Primary: Illicit Opioid Use — 35.2; 53.2 percent of opioid negative urine samples

Primary: Analgesia — 36.3; 71.8 units on a VAS scale — p=0.097

Primary: Urine Toxicology for Opiate Use — 2; 4; 2; 0 Participants

Primary: Mean Peak Opioid Withdrawal Assessed by the Clinical Opiate Withdrawal Scale (COWS) — 12.6; 1.3 units on a scale

Primary: Number of Participants Demonstrating Abstinence — 5; 4 Participants

Primary: Recruitment, Assignment to Treatment, and Retention Rates — 40; 33; 15; 32 Participants

Primary: Hepatic Safety — 278; 318; 41; 62 participants — p=< 0.05

Primary: Number of Patients Reporting Treatment-Emergent Adverse Events — 20; 21 participants

Primary: The Primary Outcome Will Include a Comparison of the Proportion of Patients Successfully Inducted One Week After the Initial Primary Care Visit. — 6; 6 participants

Primary: Pain Intensity — 5.43; 5.92; 5.28; 4.75 units on a scale

Primary: Retention Rate After 12 Months of Treatment With Suboxone — 59.9 % of participants

Primary: Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time — 35.0; 41.6 percentage of urine positive samples — p=0.77

Primary: Number of Participants Retained in Treatment — 13; 13 participants — p=0.77

Primary: Successful Naltrexone Initiation — 11 Participants

Primary: The Primary Efficacy Endpoint is a Responder Rate Analysis, Where a Responder is Defined as a Patient With no More Than 2 of 6 Months With Any Evidence of Illicit Opioid…

Primary: Retention in Treatment — 7; 5; 6 participants — p=0.32

Primary: Treatment Engagement — 23; 11; 6 participants — p=<0.001

Primary: Severity of Withdrawal Symptoms Measured Using the Clinical Opiate Withdrawal Scale (COWS) at Baseline and the Peak COWS up to 23.5 Hours After the First Administration…

Primary: The Number of Participants Attaining Successful Opioid Use Outcome by Counseling Condition at End of Phase 1 — 19; 24 participants

Primary: Number of Participants Retained in Study — 18 participants

Primary: Description of Signs and Symptoms of OIWS in Patients Who Scored Positive for Withdrawal Syndrome (OIWS) According to Diagnostic and Statistical Manual of Mental…

Primary: Percentage of Patients Who Tolerate Buprenorphine Initiation — 27 Participants

Primary: Brain Regions With Increases or Decreases in Amplitude of Low Frequency Fluctuations (ALFF) Associated With Ondansetron Administration — 0.519; 0.562; 0.478; 0.486…

Primary: OOWS Score — 3.5; 1.0; 0 units on a scale (OOWS Scale) — p=0.0001

Primary: Primary Endpoints of Retention in Treatment at Days 3 and 15 — 309; 302; 273; 269 participants

Primary: Subjects With Treatment-Emergent Adverse Events (TEAE) During the Treatment Period-Overall Safety Population — 131; 12; 58; 2 participants

Primary: Opiate Withdrawal Measured by the Subjective Opiate Withdrawal Scale (SOWS) . — 11.16; 13.36 units on a scale