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NCT02543944: GBN
Improving Treatment Outcomes for Prescription Opioid Dependence
Phase 2/Phase 3 trial testing Gabapentin in Drug Dependence in 117 participants. Completed in 31 May 2021.
25 May 2021
Quick facts
| Lead sponsor | University of Arkansas |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 117 |
| Start date | 1 February 2016 |
| Primary completion | 25 May 2021 |
| Estimated completion | 31 May 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Gabapentin (Gabapentin) — full drug profile →
- Buprenorphine (BUPRENORPHINE) — full drug profile →
- Clonidine (CLONIDINE) — full drug profile →
- Naltrexone (oral)
- Naltrexone (depot) — full drug profile →
- Placebo
Conditions studied
- Drug Dependence — all drugs for Drug Dependence →
Sponsor
University of Arkansas
Who can join
Adults 18 to 65, any sex, with Drug Dependence. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Detoxification Phase: Changes in Percent of Illicit Opioid-positive Urine Samples Over Time
Time frame: 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)
Sponsor's own description
Overall, this proposal seeks to improve treatment strategies for the significant public health problem of prescription opioid dependence by determining whether gabapentin, a non-narcotic pharmaceutical agent with minimal abuse potential and preliminary efficacy, will be effective in ameliorating withdrawal symptoms, craving and illicit drug use in prescription opioid dependent participants undergoing a 10-day detoxification from buprenorphine. In addition, the acceptability and feasibility of transitioning to depot naltrexone therapy will also be determined. If successful, this study would provide data to support further development of gabapentin as a pharmacological tool for improved outcomes during opioid detoxification as well as an integrated outpatient approach for treating prescription opioid dependence.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Randomized, placebo-controlled trial of gabapentin during outpatient buprenorphine-assisted taper and transition to injectable naltrexone.
Ray A, Mancino MJ, Thostenson JD, Guise JB, et al · · 2025 · cited 1× · PMID 41401348 · DOI 10.1080/00952990.2025.2564757
Verify or expand the search:
- PubMed search for NCT02543944
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Gabapentin
Trials testing the same drug.
- NCT07047040 — Analgesic Efficacy of Pre-operative Dose of Ketorolac and Gabapentin · Phase 2, PHASE3 · not yet recruiting
- NCT07131527 — Comparison Between Oral Gabapentin Versus Diclofenac Sodium in Post-operative Analgesia Laparoscopic Cholecystectomy · NA · recruiting
- NCT04613024 — Beneficial Side Effects of Topiramate in Obese Patients Undergoing Total Joint Arthroplasty · EARLY_PHASE1 · withdrawn
- NCT07389551 — Comparison of Pregabalin Versus Gabapentin as Pre-emptive Analgesic · NA · completed
- NCT06992427 — High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Che · Phase 3 · recruiting
Other recruiting trials for Drug Dependence
Currently open trials in the same condition.
- NCT04141202 — Structured Physical Exercise in Short-term Inpatient Treatment of Substance Use Disorder · recruiting
Other University of Arkansas trials
Trials by the same sponsor.
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- NCT07341399 — Essential Amino Acid Supplementation in Adult Spinal Deformity Patients · NA · not yet recruiting
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- NCT05823727 — Effects of Collagen Peptide Supplementation on Connective Tissue Remodeling, Functional Outcomes, and Wound Healing Afte · NA · recruiting
- NCT06604065 — Essential Amino Acids and Parkinsons Disease · Phase 1 · withdrawn
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02543944 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Arkansas
- Last refreshed: 27 July 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02543944.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing