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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01438749
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Drug: Placebo Drug: RO4917838 Drug: diazepam Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 177 participants
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Official Title: Human Abuse Liability Study in Recreational Drug Users to Investigate the Abuse Liability Potential of RO4917838
Study Start Date : October 2011
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: A Drug: diazepam
Single dose
Placebo Comparator: B Drug: Placebo
Single dose
Experimental: C Drug: RO4917838
Single doses (3 dose levels)

Primary Outcome Measures :
  1. Pharmacodynamics: Abuse potential measured by Visual analogue scales (VAS) [ Time Frame: approximately 11 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01438749

United States, Utah
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01438749     History of Changes
Other Study ID Numbers: BP25259
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Muscle Relaxants, Central
Neuromuscular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action