drugset / Trial / NCT02543944

Improving Treatment Outcomes for Prescription Opioid Dependence

NCT02543944

RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2016-02
Primary completion
2021-05-25
Completion
2021-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Gabapentin Small molecule 800 mg
Comparator Naltrexone Small molecule 6.25 mg Oral
Comparator Naltrexone Small molecule 25 mg Oral
Comparator Naltrexone Small molecule 50 mg Oral
Comparator Buprenorphine Other / unclassified 12 mg
Comparator Clonidine Other / unclassified 0.1 mg

Indications