Trial · NCT02543944
Improving Treatment Outcomes for Prescription Opioid Dependence
NCT02543944, Phase 2, Phase 3, Completed, University of Arkansas; results first posted 2022-07-28
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Improving Treatment Outcomes for Prescription Opioid Dependence. Trials, record NCT02543944. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02543944
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Improving Treatment Outcomes for Prescription Opioid Dependence
- NCT number
- NCT02543944
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 117 participants, actual
- Lead sponsor
- University of Arkansas
- Conditions
- Drug Dependence
- Interventions
- Gabapentin, Buprenorphine, Clonidine, Naltrexone (oral), Naltrexone (depot), Placebo
- First posted
- 2015-09-07
- Last updated
- 2022-07-28
- Results first posted
- 2022-07-28
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time | Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition) | Thrice weekly urine samples obtained during weeks 1-3; data include assessments from week 1 day 1 through week 4 day 1 (up to 10 total samples per participant) |
| Secondary | NTX Transition Initiation | 3 days (wk 4 day 1 - week 4 day 3) | % of Participants who completed the detox and started the NTX transition |
| Secondary | Vivitrol Injection Receivers | 5 days (week 4 day 1 to week 4 day 5) | % of participants starting the NTX transition who received Vivitrol injection |
| Secondary | Detox Phase Completers | 3 weeks (week 1-3) | % of enrolled participants who completed the Detox Phase |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time | Week 1 day 1 (study entry) through Week 4 day 1 (first day of NTX transition) | those starting on study medication | percentage of urine positive samples | MEAN |
| SECONDARY | NTX Transition Initiation | 3 days (wk 4 day 1 - week 4 day 3) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Vivitrol Injection Receivers | 5 days (week 4 day 1 to week 4 day 5) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Detox Phase Completers | 3 weeks (week 1-3) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time | Gabapentin | 35.0 | Standard Deviation 36.7 | percentage of urine positive samples | |
| Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time | Placebo | 41.6 | Standard Deviation 38.5 | percentage of urine positive samples | |
| NTX Transition Initiation | Gabapentin | 33 | Participants | ||
| NTX Transition Initiation | Placebo | 29 | Participants | ||
| Vivitrol Injection Receivers | Gabapentin | 12 | Participants | ||
| Vivitrol Injection Receivers | Placebo | 12 | Participants | ||
| Detox Phase Completers | Gabapentin | 41 | Participants | ||
| Detox Phase Completers | Placebo | 34 | Participants |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1: GBN/BUP Induction and BUP Detox | STARTED | Gabapentin | 60 | |
| Phase 1: GBN/BUP Induction and BUP Detox | STARTED | Placebo | 57 | |
| Phase 1: GBN/BUP Induction and BUP Detox | COMPLETED | Gabapentin | 41 | |
| Phase 1: GBN/BUP Induction and BUP Detox | COMPLETED | Placebo | 34 | |
| Phase 1: GBN/BUP Induction and BUP Detox | NOT COMPLETED | Gabapentin | 19 | |
| Phase 1: GBN/BUP Induction and BUP Detox | NOT COMPLETED | Placebo | 23 | |
| Phase 2: Transition From BUP to XR-NTX | STARTED | Gabapentin | 33 | |
| Phase 2: Transition From BUP to XR-NTX | STARTED | Placebo | 29 | |
| Phase 2: Transition From BUP to XR-NTX | COMPLETED | Gabapentin | 12 | |
| Phase 2: Transition From BUP to XR-NTX | COMPLETED | Placebo | 12 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events180
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 |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Gabapentin | 0 | 60 | 0 |
| other | Nausea | Gastrointestinal disorders | Placebo | 5 | 57 | 5 |
| other | Vomiting | Gastrointestinal disorders | Gabapentin | 4 | 60 | 4 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 3 | 57 | 3 |
| other | Heartburn | Gastrointestinal disorders | Gabapentin | 1 | 60 | 1 |
| other | Heartburn | Gastrointestinal disorders | Placebo | 0 | 57 | 0 |
| other | Stomach cramps | Gastrointestinal disorders | Gabapentin | 0 | 60 | 0 |
| other | Stomach cramps | Gastrointestinal disorders | Placebo | 1 | 57 | 1 |
| other | Abdominal pain/soreness | Gastrointestinal disorders | Gabapentin | 2 | 60 | 2 |
| other | Abdominal pain/soreness | Gastrointestinal disorders | Placebo | 0 | 57 | 0 |
1 to 10 of 180Source ClinicalTrials.gov
See all 180 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | 0 | 60 |
| Total, all-cause mortality | Placebo | 0 | 57 |
| Total, other adverse events | Gabapentin | 43 | 60 |
| Total, other adverse events | Placebo | 37 | 57 |
| Total, serious adverse events | Gabapentin | 0 | 60 |
| Total, serious adverse events | Placebo | 0 | 57 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41401348 | DERIVED |
Source PubMed
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 |
|---|---|---|---|---|---|
| R01DA039088 | Improving Treatment Outcomes for Prescription Opioid Dependence | OLIVETO, ALISON; MANCINO, MICHAEL J | UNIV OF ARKANSAS FOR MED SCIS | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2019 |
Source NIH RePORTER
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Gabapentin vs Placebo: Vivitrol Injection Receivers | Trial comparisons |
| Gabapentin vs Placebo: Detox Phase Completers | Trial comparisons |
| Gabapentin vs Placebo: NTX Transition Initiation | Trial comparisons |
| Gabapentin vs Placebo: deaths from any cause | Trial comparisons |
| Gabapentin vs Placebo: serious adverse events | Trial comparisons |
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/NCT02543944
GET https://conductscience.org/api/trials/v1/NCT02543944/events?page=2