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

NCT01438749 | Completed Phase 1

• 1 other identifier: BP25259
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

• Pharmacodynamics: Abuse potential measured by Visual analogue scales (VAS)

  approximately 11 months

Secondary Outcomes (3)

• Safety: Incidence of adverse events

  approximately 11 months

• Pharmacokinetics: plasma concentrations of RO4917838

  approximately 11 months

• Pharmacodynamics: Addiction Research Center Inventory (ARCI) subscales

  approximately 11 months

Study Arms (3)

A

ACTIVE COMPARATOR

Drug: diazepam

B

PLACEBO COMPARATOR

Drug: Placebo

C

EXPERIMENTAL

Drug: RO4917838

Interventions

Placebo DRUG

Single dose

B

RO4917838 DRUG

Single doses (3 dose levels)

C

diazepam DRUG

Single dose

A

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Salt Lake City, Utah, 84106, United States

Location

MeSH Terms

Interventions

Diazepam

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2011
• First Posted: September 22, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)