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NCT Number: NCT01438749

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

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.

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Key information

Conditions

Healthy Volunteer

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Salt Lake City, Utah, 84106, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Placebo

Drug

Single dose

RO4917838

Drug

Single doses (3 dose levels)

Diazepam

Drug

Single dose

Primary outcomes

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

    Time frame: approximately 11 months

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 11 months

  2. Pharmacokinetics: plasma concentrations of RO4917838

    Time frame: approximately 11 months

  3. Pharmacodynamics: Addiction Research Center Inventory (ARCI) subscales

    Time frame: approximately 11 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 22, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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