Trial · NCT00420771
Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
NCT00420771, Phase 2, Completed, New York State Psychiatric Institute; results first posted 2018-07-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients. Trials, record NCT00420771. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00420771
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gabapentin Treatment of Benzodiazepine Abuse in Methadone Maintenance Patients
- NCT number
- NCT00420771
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- New York State Psychiatric Institute
- Conditions
- Benzodiazepine Dependence, Opioid Dependence
- Interventions
- Gabapentin, Placebo
- First posted
- 2007-01-11
- Last updated
- 2019-04-24
- Results first posted
- 2018-07-12
- Limitations and caveats
An adequately powered double-blind trial is required to further evaluate the utility of gabapentin in treating benzodiazepine use disorder. Recruitment from more than one program is likely to be required to reach an adequate sample size.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back | data collected during 8 weeks of trial or length of participation | Comparing the mean reduction change in Benzodiazepine use per day when comparing the baseline week prior to study entry to the last week of study participation based on the Time Line Follow Back |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back | data collected during 8 weeks of trial or length of participation | a total of 16 participants had data available post randomization | milligrams/day | MEAN |
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 |
|---|---|---|---|---|---|
| Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back | Active Medication | 4.0 | Standard Deviation 4.0 | milligrams/day | |
| Mean Reduction Change in Benzodiazepine Use Per Day Based on Time Line Follow Back | Placebo | 2.3 | Standard Deviation 6.7 | milligrams/day |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Gabapentin | 8 | |
| Overall Study | STARTED | Placebo | 11 | |
| Overall Study | COMPLETED | Gabapentin | 5 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | NOT COMPLETED | Gabapentin | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events8
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 | fatigue | General disorders | Gabapentin | 3 | 6 | 3 |
| other | fatigue | General disorders | Placebo | 2 | 10 | 2 |
| other | somnalence | General disorders | Gabapentin | 5 | 6 | 5 |
| other | somnalence | General disorders | Placebo | 2 | 10 | 2 |
| other | dizziness | General disorders | Gabapentin | 4 | 6 | 4 |
| other | dizziness | General disorders | Placebo | 0 | 10 | 0 |
| other | other | General disorders | Gabapentin | 0 | 6 | 0 |
| other | other | General disorders | Placebo | 1 | 10 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Gabapentin | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Gabapentin | 6 | 6 |
| Total, other adverse events | Placebo | 5 | 10 |
| Total, serious adverse events | Gabapentin | 0 | 6 |
| Total, serious adverse events | Placebo | 0 | 10 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26962719 | 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 |
|---|---|---|---|---|---|
| K23DA021209 | Anticonvulsant Pharmacotherapy for Sedative-Hypnotic Use Disorders | MARIANI, JOHN J | COLUMBIA UNIVERSITY HEALTH SCIENCES | NATIONAL INSTITUTE ON DRUG ABUSE | 2006 to 2010 |
Source NIH RePORTER
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Gabapentin vs Placebo: serious adverse events |
Source 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/NCT00420771
GET https://conductscience.org/api/trials/v1/NCT00420771/registered