A Study of The Abuse Liability Potential of RO4917838 in Recreational Drug Users

Healthy Volunteer Clinical Trial

Official title:

Human Abuse Liability Study in Recreational Drug Users to Investigate the Abuse Liability Potential of RO4917838

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438749
• Other study ID #: BP25259
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2011
• Last updated: November 1, 2016
• Start date: October 2011
• Est. completion date: May 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This randomized, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of RO4917838 in recreational drug users. In a pre-study (Part 1), subjects will receive a single dose of either diazepam or placebo in an inpatient crossover design, with a wash-out period of at least 10 days between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the main study (Part 2) and will be randomized to single oral doses of RO4917838 (3 dose levels), diazepam and placebo in a double-blind, double-dummy inpatient crossover design. Washout-periods between the 5 treatment periods in Part 2 will be at least 10 days.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 177
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male or female volunteers, 18 to 55 years of age inclusive

• Recreational drug abuse experience (>/= 10 times lifetime abuse of a CNS depressant, >/= 1 abuse of CNS depressant in the previous 3 months

• Body mass index (BMI) 18 to 30 kg/m2 inclusive

• Main study (Part 2): Able to differentiate between diazepam and placebo

Exclusion Criteria:

• History of any significant disease or disorder

• History or current diagnosis of substance dependence (excluding caffeine and nicotine)

• Currently seeking or history of participating in treatment for substance-related disorders, including successful completion of such treatment

• Any confirmed significant allergic reactions against any drug, or multiple allergies in the judgement of the investigator

• Positive for hepatitis B, hepatitis C or HIV infection

• Pregnant or lactating women

• Participation in an investigational drug or device study within the last 30 days prior to Day 1 of the study

• Confirmed positive drug screening at screening / any Day -1 (allowed positive THC at screening and any Day -1 and positive benzodiazepine at screening only)

• Positive alcohol breath test at screening / any Day -1

• Heavy smoker (> 20 cigarettes, > 8 pipefuls or > 8 cigars per day)

Study Design

Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Placebo
Single dose
• RO4917838
Single doses (3 dose levels)
• diazepam
Single dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamics: Abuse potential measured by Visual analogue scales (VAS)		approximately 11 months	No
Secondary	Safety: Incidence of adverse events		approximately 11 months	No
Secondary	Pharmacokinetics: plasma concentrations of RO4917838		approximately 11 months	No
Secondary	Pharmacodynamics: Addiction Research Center Inventory (ARCI) subscales		approximately 11 months	No