Trial · NCT03447743
Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
NCT03447743, Early phase 1, Completed, Michele Staton; results first posted 2023-03-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder. Trials, record NCT03447743. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03447743
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Re-entry XR-NTX for Rural Individuals With Opioid Use Disorder
- NCT number
- NCT03447743
- Status
- Completed
- Phases
- Early phase 1
- Enrollment
- 9 participants, actual
- Lead sponsor
- Michele Staton
- Conditions
- Opioid Dependence
- Interventions
- XR-NTX community location
- First posted
- 2018-02-27
- Last updated
- 2023-03-27
- Results first posted
- 2023-03-27
- Limitations and caveats
* Number of individuals re-entering the community onto supervision in the specified county~* Overall small sample size that was able to be recruited~* COVID-19 (coronavirus) shut down recruiting in criminal justice settings for part of the study period
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Study Enrollment | 3 months | Study enrollment is defined as the number of participants who initiate XR-NTX. |
| Secondary | Number of Participants With Opioid Relapse | 3 months | The short-term outcome of interest includes any relapse to opioid use (any use of opioids by self-report and urine drug screen; continuous measure of number of days of use). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Study Enrollment | 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Opioid Relapse | 3 months | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Study Enrollment | XR-NTX Services as Usual | 7 | Participants | ||
| Number of Participants With Opioid Relapse | XR-NTX Services as Usual | 3 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Extended Release Naltrexone (XR-NTX) Services as Usual | 9 | |
| Overall Study | COMPLETED | Extended Release Naltrexone (XR-NTX) Services as Usual | 2 | |
| Overall Study | NOT COMPLETED | Extended Release Naltrexone (XR-NTX) Services as Usual | 7 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Hospitalization | Hepatobiliary disorders | XR-NTX Services as Usual | 1 | 9 | 1 |
| serious | Hospitalization | Injury, poisoning and procedural complications | XR-NTX Services as Usual | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | XR-NTX Services as Usual | 0 | 9 |
| Total, other adverse events | XR-NTX Services as Usual | 0 | 9 |
| Total, serious adverse events | XR-NTX Services as Usual | 1 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34DA045856 | Re-entry XR-NTX for rural opioid dependent women | STATON, MICHELE | UNIVERSITY OF KENTUCKY | NATIONAL INSTITUTE ON DRUG ABUSE | 2018 to 2020 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03447743
GET https://conductscience.org/api/trials/v1/NCT03447743/registered