Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse

Phase 2 Completed 14 enrolled Takeda

RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to determine the relative abuse potential of ramelteon, once daily (QD), compared to triazolam in subjects with a history of drug abuse.

Timeline

Start: 2003-06
Primary completion: 2003-12
Completion: 2003-12

Publications

Results Johnson MW, Suess PE, Griffiths RR. Ramelteon: a novel hypnotic lacking abuse liability and sedative adverse effects. Arch Gen Psychiatry. 2006 Oct;63(10):1149-57. doi: 10.1001/archpsyc.63.10.1149.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ramelteon	Unknown	16 mg	Oral
Subject	Ramelteon	Unknown	80 mg	Oral
Subject	Ramelteon	Unknown	160 mg	Oral
Subject	Triazolam	Small molecule	0.25 mg	Oral
Subject	Triazolam	Small molecule	0.5 mg	Oral
Subject	Triazolam	Small molecule	0.75 mg	Oral

Behavioral and Subjective Efficacy of Ramelteon in Subjects With a History of Polydrug Abuse

Summary

Timeline

Publications

Drugs

Indications