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

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

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

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

Primary: Percentage of Positive Toxicology Swabs for Illicit Substances — 81.3; 79.1; 86.2; 82.3 percentage of positive toxicology screen

Primary: Abuse Liability Proxy — 0.197; 0.483; 0.159; 7.678 units on a scale (points 0-100) — p=<.05

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

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

Primary: Changes in Resting State Disorganization Between Baseline and One Week by Person by Lapsed Category — 0.315; 0.328; 0.384; 0.394 Mean default mode network (DMN) z-scores

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

Primary: Change From Week 0 in Cannabis Use Using Urinary CN-THCCOOH Levels at Week 8 — -334.21; -359.95 ng/mg

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

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: Number of Participants Retained in Study — 18 participants

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

Primary: 3 Scores on the Addiction Research Center Inventory (ARCI) — 7.6; 5.4; 5.2; 3.3 scores on a scale

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

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

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 With Dose Limiting Toxicities — 0; 0; 0; 0 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: 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: Participant Acceptability of the Interventions — 1; 0 Participants

Primary: Mean Ratings on Clinical Opiate Withdrawal Scale (COWS) Measure of Withdrawal During Double-blind Taper (7-days) and Post-taper (7-days) Period. — 7.79; 8.41; 8.28; 6.16…

Primary: Successful Naltrexone Initiation — 11 Participants

Primary: Changes in Cue-Induced In-Clinic Craving (From Baseline to Post-cue or Post-neutral - Via the Visual Analog Scale for Craving (VASC) — 2.67; 0.83; -0.33; -0.17 units on…