Modulation of opiate reward by NK1 antagonism: a laboratory based proof of concept study

INTERVENTION: Trade Name: Emend Pharmaceutical Form: Capsule, hard CAS Number: 170729‐80‐3 Current Sponsor code: Apr Other descriptive name: APREPITANT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: ‐125 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Subutex Pharmaceutical Form: Sublingual tablet INN or Proposed INN: BUPRENORPHINE CAS Number: 52485797 Current Sponsor code: bup Concentration unit: mg milligram(s) Concentration type: equal Concentration number: ‐8 Trade Name: Subutex Pharmaceutical Form: Sublingual tablet INN or Proposed INN: BUPRENORPHINE CAS Number: 52485797 Current Sponsor code: bup Concentration unit: mg milligram(s) Concentration type: equal Concentration number: ‐0.4 CONDITION: opiate abuse ; MedDRA version: 9.1 Level: LLT Classification code 10039004 Term: Reversal of opiate activity ; MedDRA version: 9.1 Level: LLT Classification code 10012346 Term: Dependence on opiates PRIMARY OUTCOME: Main Objective: To evaluate the NK1 antagonist aprepitant for its ability to block physiological and psychological effects of opiate receptor activation Primary end point(s): Subjective psychological responses to opiate challene Secondary Objective: INCLUSION CRITERIA: Subjects will be eligible if they are aged 18 – 50 years and have current opiate use Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range