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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01438749
First received: September 21, 2011
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteer
 Drug: RO4917838
Drug: diazepam
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Human Abuse Liability Study in Recreational Drug Users to Investigate the Abuse Liability Potential of RO4917838

Resource links provided by NLM:

Drug Information available for: Diazepam
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pharmacodynamics: Abuse potential measured by Visual analogue scales (VAS) [ Time Frame: approximately 11 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: approximately 11 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: plasma concentrations of RO4917838 [ Time Frame: approximately 11 months ] [ Designated as safety issue: No ]
  • Pharmacodynamics: Addiction Research Center Inventory (ARCI) subscales [ Time Frame: approximately 11 months ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: October 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: diazepam
Single dose
Placebo Comparator: B Drug: Placebo
Single dose
Experimental: C Drug: RO4917838
Single doses (3 dose levels)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438749

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

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01438749     History of Changes
Other Study ID Numbers: BP25259
Study First Received: September 21, 2011
Last Updated: March 4, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diazepam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
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
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia

ClinicalTrials.gov processed this record on May 19, 2013