Trial · NCT05382091
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
21 to 29 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Secondary | Abstinence from drugs of abuse by Timeline Followback (TLFB) | At every study visit through Week 60 except for days of implant procedures. | Proportion of participants who maintain abstinence from opioids, benzodiazepines; barbiturates; cocaine; amphetamine; methamphetamine; phencyclidine (PCP); ecstasy (MDMA); and marijuana (THC) as measured through a urine drug screen (UDS) |
| Secondary | Abstinence from alcohol | pre-dose (prior to each implant procedure) and at every study visit through Week 60. | Proportion of participants who maintain abstinence from alcohol as measured using and alcohol breathalyzer |
| Secondary | Opioid craving (VAS) | pre-dose (prior to each implant procedure) and at every study visit through Week 60. | The craving for opioids will be measured using a horizontal visual analog scale (VAS), which ranges from 0 (no craving) to 10 (most intense craving possible). |
| Secondary | Opioid withdrawal (SOWS) | pre-dose (prior to each implant procedure) and at every study visit through Week 60. | The SOWS is a 16-item questionnaire designed to measure the severity of opioid withdrawal symptoms. The participant rates the intensity of symptoms using a 5-point scale; with 0 representing "not at all" and 4 representing "extremely". |
| Secondary | Opioid withdrawal (COWS) | pre-dose (prior to each implant procedure) and at every study visit through Week 60. | The COWS is a questionnaire designed to measure 11 common opioid withdrawal signs and symptoms. The summed score provides information about the severity of opioid withdrawal and the level of physical dependence on opioids. Total scores range from 0 to 47, and withdrawal is classified as mild (5-12), moderate (13-24), moderately severe (25-36), or severe (\>36) |
| Secondary | Hamilton Depression Rating Scale (HDRS) | At every study visit through Week 60 except for days of implant procedures. | Assessment of Depression/Mood via the HDRS, is a clinician-administered instrument, useful for following both depression and suicidal ideation, and for following typical symptoms of subacute withdrawal (e.g., low appetite, fatigue, poor sleep). A score of 1 or more to item 3 (suicidality) prompts a clinician assessment for suicide risk before leaving the clinic. |
| Secondary | Brief Symptom Inventory 18 (BSI-18) | Baseline, Day 28, Day 42, Day 56, Day 84, and then every 28 days until Week 60. | Assessment of Depression/Mood via the BSI-18; comprising 18 items (ranging from 0 = not at all to 4 = extremely), assesses psychiatric symptoms in three distinct domains: depression, anxiety, and somatization. The total score ranges from 0 to 72 with higher scores indicating higher symptom severity. |
| Secondary | Quality of Life Score (QoL) | Day 28, Day 42, Day 56, Day 84, and then every 28 days until Week 60. | Quality of life as measured through Quality of Life Enjoyment and Satisfaction Questionnaire (short form). is a 16 item self-administered questionnaire that captures life satisfaction over the past week. Each question is rated on a 5 point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as percentage maximum possible score. The Total Score is reported as percentage maximum possible % Max = Raw-minimum score/maximum score-minimum score. (Raw score minus the minimum possible raw score divided by the maximum possible raw score minus the minimum possible raw score). If items are left blank the maximum and minimum scores must be modified to reflect the number of items scored. |
| Secondary | Treatment Satisfaction (TSQM-14) | Repeat implant procedure days and at Week 60. | The TSQM-14 is comprised of 14 questions that provide scores on four scales: effectiveness (3 items), side effects (5 items), convenience (3 items) and global satisfaction (3 items). With the exception of item 4 (presence of side effects; yes or no), all items have five or seven responses, scored from one (least satisfied) to five or seven (most satisfied). Item scores are summed to give four domain scores, which are in turn transformed to a scale of 0-100 |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05382091/registered?page=2