Trial · NCT02032433
Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
NCT02032433, Phase 4, Completed, NYU Langone Health; results first posted 2018-01-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment. Trials, record NCT02032433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02032433
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
- NCT number
- NCT02032433
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 570 participants, actual
- Lead sponsor
- NYU Langone Health
- Conditions
- Opioid Use Disorder
- Interventions
- Extended-Release Naltrexone, Buprenorphine-Naloxone
- First posted
- 2014-01-10
- Last updated
- 2020-08-13
- Results first posted
- 2018-01-19
Source ClinicalTrials.gov
Registered outcomes58
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 registered outcomesOutcomes58
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Relapse (Intent to Treat Population) | Weeks 3-24 | Intention to treat. | weeks | MEDIAN |
| PRIMARY | Time to Relapse (Per Protocol Population) | Weeks 3-24 | Per protocol population (those successfully inducted onto medication) | weeks | MEDIAN |
| SECONDARY | Number Successfully Inducted Onto Assigned Study Medication | Weeks 0-24 | Intent to treat | participants | NUMBER |
| SECONDARY | Adverse Events Related to Study Medications | Weeks 0-36 | These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication. | events | NUMBER |
| SECONDARY | Opioid Abstinence Over Time While on Study Medication (Subjective) | Weeks 0-24 | per protocol | days | MEDIAN |
| SECONDARY | Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 | Week 0 | drinks per day | MEAN | |
| SECONDARY | Cigarette Smoking, W0, 10 or Less | Week 0 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Opioid Craving Over Time W0 | Week 0 | score on a scale | MEAN | |
| SECONDARY | Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale | Week 0 | score on a scale | MEAN | |
| SECONDARY | Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale | Week 0 | score on a scale | MEAN |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 outcomesResults by group116
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Relapse (Intent to Treat Population) | Extended-Release Naltrexone | 8.4 | 95% Confidence Interval 3.0 to 23.4 | weeks | |
| Time to Relapse (Intent to Treat Population) | Buprenorphine-Naloxone | 14.4 | 95% Confidence Interval 5.1 to 23.4 | weeks | |
| Time to Relapse (Per Protocol Population) | Extended-Release Naltrexone | 20.4 | 95% Confidence Interval 5.4 to 23.4 | weeks | |
| Time to Relapse (Per Protocol Population) | Buprenorphine-Naloxone | 15.2 | 95% Confidence Interval 5.7 to 23.4 | weeks | |
| Number Successfully Inducted Onto Assigned Study Medication | Extended-Release Naltrexone | 204 | participants | ||
| Number Successfully Inducted Onto Assigned Study Medication | Buprenorphine-Naloxone | 270 | participants | ||
| Adverse Events Related to Study Medications | Extended-Release Naltrexone | 115 | events | ||
| Adverse Events Related to Study Medications | Buprenorphine-Naloxone | 113 | events | ||
| Opioid Abstinence Over Time While on Study Medication (Subjective) | Extended-Release Naltrexone | 123 | Inter-Quartile Range 18 to 144 | days | |
| Opioid Abstinence Over Time While on Study Medication (Subjective) | Buprenorphine-Naloxone | 87 | Inter-Quartile Range 20 to 144 | days |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Extended-Release Naltrexone | 283 | |
| Overall Study | STARTED | Buprenorphine-Naloxone | 287 | |
| Overall Study | COMPLETED | Extended-Release Naltrexone | 205 | |
| Overall Study | COMPLETED | Buprenorphine-Naloxone | 225 | |
| Overall Study | NOT COMPLETED | Extended-Release Naltrexone | 78 | |
| Overall Study | NOT COMPLETED | Buprenorphine-Naloxone | 62 |
Source ClinicalTrials.gov
Adverse events72
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 | Gastrointestinal | Gastrointestinal disorders | Extended-Release Naltrexone | 36 | 283 | |
| other | Gastrointestinal | Gastrointestinal disorders | Buprenorphine-Naloxone | 58 | 287 | |
| other | Psychiatric | Psychiatric disorders | Extended-Release Naltrexone | 29 | 283 | |
| other | Psychiatric | Psychiatric disorders | Buprenorphine-Naloxone | 22 | 287 | |
| other | Injury poisoning and procedural complications | Injury, poisoning and procedural complications | Extended-Release Naltrexone | 18 | 283 | |
| other | Injury poisoning and procedural complications | Injury, poisoning and procedural complications | Buprenorphine-Naloxone | 22 | 287 | |
| other | Infections and infestations | Infections and infestations | Extended-Release Naltrexone | 22 | 283 | |
| other | Infections and infestations | Infections and infestations | Buprenorphine-Naloxone | 22 | 287 | |
| other | Nervous system disorders | Nervous system disorders | Extended-Release Naltrexone | 29 | 283 | |
| other | Nervous system disorders | Nervous system disorders | Buprenorphine-Naloxone | 27 | 287 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Extended-Release Naltrexone | 3 | 283 |
| Total, all-cause mortality | Buprenorphine-Naloxone | 4 | 287 |
| Total, other adverse events | Extended-Release Naltrexone | 118 | 283 |
| Total, other adverse events | Buprenorphine-Naloxone | 135 | 287 |
| Total, serious adverse events | Extended-Release Naltrexone | 41 | 283 |
| Total, serious adverse events | Buprenorphine-Naloxone | 31 | 287 |
Source ClinicalTrials.gov
Papers14
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|---|---|---|---|
| UG1DA013035 | NIDA Clinical Trials Network: New York Node - Renewal-GY24 | MCNEELY, JENNIFER; CAMPBELL, AIMEE N; NUNES, EDWARD V. | NEW YORK UNIVERSITY SCHOOL OF MEDICINE | NATIONAL INSTITUTE ON DRUG ABUSE | 2015 to 2025 |
Source NIH RePORTER
Trial comparisons19
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Other Drug Use Over Time, Stimulant, W24 | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Other Drug Use Over Time, Cannabis, W24 | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Cigarette Smoking, W0 0 | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Cigarette Smoking, W0 11-20 | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Other Drug Use Over Time, Stimulant, W0 | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Other Drug Use Over Time, Cannabis, W0 | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Cigarette Smoking, W0, 10 or Less | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Cigarette Smoking, W24 31 or More | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Number Successfully Inducted Onto Assigned Study Medication | Trial comparisons |
| Extended-Release Naltrexone vs Buprenorphine-Naloxone: Cigarette Smoking, W24 21-30 | Trial comparisons |
1 to 10 of 19
See all 19 trial comparisonsTests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
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/NCT02032433
GET https://conductscience.org/api/trials/v1/NCT02032433/registered?page=2