Trial · NCT02032433
Registered outcomes58
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 58
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Relapse (Intent to Treat Population) | Weeks 3-24 | Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week. |
| Primary | Time to Relapse (Per Protocol Population) | Weeks 3-24 | Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week. |
| Secondary | Number Successfully Inducted Onto Assigned Study Medication | Weeks 0-24 | Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication. |
| Secondary | Adverse Events Related to Study Medications | Weeks 0-36 | Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor. |
| Secondary | Opioid Abstinence Over Time While on Study Medication (Subjective) | Weeks 0-24 | Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter. |
| Secondary | Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 | Week 0 | Alcohol use over time, drinks per day, past 30 days, at week 0 |
| Secondary | Cigarette Smoking, W0, 10 or Less | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less. |
| Secondary | Opioid Craving Over Time W0 | Week 0 | Opioid craving over time via VAS at week 0 |
| Secondary | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale | Week 0 | The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression. |
| Secondary | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem. |
| Secondary | Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) | Week 0 | The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior. |
| Secondary | Score on Trail Making Test Part A | Week 0 | Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment. |
| Secondary | Opioid Abstinence Over Time While on Study Medication (Objective) | Weeks 0-24 | A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits. |
| Secondary | Cigarette Smoking, W0 0 | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals none |
| Secondary | Cigarette Smoking, W0 11-20 | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20. |
| Secondary | Cigarette Smoking, W0 21-30 | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30 |
| Secondary | Cigarette Smoking, W0 31 or More | Week 0 | Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more |
| Secondary | Cigarette Smoking, W24 0 | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals none |
| Secondary | Cigarette Smoking | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less. |
| Secondary | Cigarette Smoking, W24 11-20 | Week 24 | Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT02032433/registered