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Medications Development for the Treatment of Cannabis Related Disorders (MTC)

Primary Purpose

Nicotine Withdrawal, Marijuana Dependence, Cannabis Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placebo Aprepitant
Active Aprepitant
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Nicotine Withdrawal focused on measuring Marijuana Abuse, Nicotine Dependence, Nicotine Withdrawal, neurokinin Receptor, NK1 Receptor antagonist, Substance P, Recurrence, Substance Withdrawal Syndrome, Substance-Related Disorders, Disorders of Environmental Origin, Mental Disorders, Disease Attributes, Pathologic Processes, Tetrahydrocannabinol, Therapeutic Uses, Psychotropic Drugs, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Narcotic Antagonists, cannabis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Must meet DSM-IV/ICD-10 criteria for cannabis abuse or dependence
  • Must be non-treatment seeking individuals
  • Participant does not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) dependence on a substance other than alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification.
  • No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data
  • Not currently taking other medications (with the exception of oral contraceptives) that would preclude safe participation in this study
  • Must test negative for pregnancy prior to inclusion
  • females using birth control pills must agree to use a condom during intercourse for 1 month after participation in study because the study medication will decrease the effectiveness of the birth control pill rendering it ineffective
  • Should be in general good health
  • No evidence of recent use of other illicit drugs on a urine toxicity screen prior to admission

Exclusion Criteria:

  • Major current (within last 90 days) Axis I psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia)
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, cancer, epilepsy, kidney disease)
  • Current, repeated illicit drug use (other than marijuana)
  • Subject is breastfeeding or pregnant
  • Concurrent therapy with drugs known to inhibit CYP3A4 activity
  • Request for drug treatment
  • Current parole or probation
  • Recent history of significant violent or suicide behavior
  • Allergic to sesame oil

Sites / Locations

  • Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine
  • University of Virginia Center for Addiction Education and Treatment (UVA CARE)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Behavioral Condition 1

Behavioral Condition 2

Behavioral Condition 3

Arm Description

Nicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)

Placebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)

Placebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)

Outcomes

Primary Outcome Measures

withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale
Subjective experience of withdrawal symptoms for cannabis, tobacco, and both (eg: Irritability, Sleep difficulty, Chills, Nervousness)
"craving" measured using the Marijuana craving questionaire and the tobacco craving questionaire
Subjective measures of craving for cannabis, tobacco, and both Questionaires are anchored with strongly disagree to strongly agree (1-7)
reinforcing effects, as measured using the Multiple Choice Questionaire
Reinforcement value of cannabis and tobacco as measured by preference for money over the administration of either drug; questionaire has 70 questions and money value vs. drug ranges from 25 cents to 25 dollars 1-70.

Secondary Outcome Measures

sleep quality
A VAS sleep questionnaire will be used each morning to assess daily sleep quality.
Neurocognitive Function
The purpose of examining the neurocognitive function of our participants on days 1-4 is to examine the safety of the co-administration of aprepitant at 160 mg/day with oral THC (dronabinol 10 mg) on brain function. Tasks used are the DSST - The Digit Symbol Substitution Test measures the learning of integrating visual and motor skills, and the SRTT- The Simple reaction Time Task is a well validated computerized test for assessing the effects of psychoactive drugs on performance.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Blood pressure, pulse, and a Systematic Assessment For Treatment Emergent Events (SAFTEE) are collected daily. Electrocardiograms (EKGs) are collected at baseline and discharge.

Full Information

First Posted
September 14, 2010
Last Updated
May 31, 2012
Sponsor
University of Virginia
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01204723
Brief Title
Medications Development for the Treatment of Cannabis Related Disorders
Acronym
MTC
Official Title
Medications Development for the Treatment of Cannabis Related Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Virginia
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this application is to test the neurobehavioral mechanisms and effects of aprepitant as a new cessation agent for cannabis, tobacco or both.
Detailed Description
Stress (emotional, physical, social) facilitates drug seeking behavior through the activation of the HPA axis, autonomic nervous system, and brain DA systems. Furthermore, alterations within several neuropeptide systems (CRF, Substance P, and others) also contribute to the role of stress in addiction. Central to this project is that anxiety and stress responses are modulated by substance P and its preferred target, the NK1 receptor. Therefore the aim of this pilot clinical trial is to determine the safety and efficacy of aprepitant (a neurokinin 1 (NK1) receptor antagonist). We hypothesize that the NK1 receptor antagonist, aprepitant, will be safe, tolerable and efficacious at reducing the withdrawal symptoms, cue craving, and reinforcement value for both cannabis and tobacco resulting from the cessation of either or both drugs. We will assess this hypothesis in the context of a carefully controlled human laboratory study in which subjects (N=72) will be randomized in a 3 x 2 factorial design to one of 3 behavioral conditions; a) withdrawn from both substances, b) withdrawn from tobacco only, or c) withdrawn from cannabis only, and to receive one of 2 medication dose conditions: placebo or aprepitant (160 mg/day). Medication will be administered for 5 days, followed by a cue challenge, choice procedure, and then a consequence (i.e., oral cannabis or a cigarette or money) also on day 5.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Withdrawal, Marijuana Dependence, Cannabis Dependence, Nicotine Dependence, Cannabis Abuse
Keywords
Marijuana Abuse, Nicotine Dependence, Nicotine Withdrawal, neurokinin Receptor, NK1 Receptor antagonist, Substance P, Recurrence, Substance Withdrawal Syndrome, Substance-Related Disorders, Disorders of Environmental Origin, Mental Disorders, Disease Attributes, Pathologic Processes, Tetrahydrocannabinol, Therapeutic Uses, Psychotropic Drugs, Analgesics, Non-Narcotic, Analgesics, Sensory System Agents, Peripheral Nervous System Agents, Neurotransmitter Agents, Molecular Mechanisms of Pharmacological Action, Narcotic Antagonists, cannabis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Condition 1
Arm Type
Experimental
Arm Description
Nicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
Arm Title
Behavioral Condition 2
Arm Type
Experimental
Arm Description
Placebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
Arm Title
Behavioral Condition 3
Arm Type
Experimental
Arm Description
Placebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
Intervention Type
Drug
Intervention Name(s)
Placebo Aprepitant
Intervention Description
Placebo Aprepitant 0 mg once daily for 5 days
Intervention Type
Drug
Intervention Name(s)
Active Aprepitant
Intervention Description
Active Aprepitant 160 mg once daily for 5 days
Primary Outcome Measure Information:
Title
withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale
Description
Subjective experience of withdrawal symptoms for cannabis, tobacco, and both (eg: Irritability, Sleep difficulty, Chills, Nervousness)
Time Frame
collected on each study day
Title
"craving" measured using the Marijuana craving questionaire and the tobacco craving questionaire
Description
Subjective measures of craving for cannabis, tobacco, and both Questionaires are anchored with strongly disagree to strongly agree (1-7)
Time Frame
collected on each study day
Title
reinforcing effects, as measured using the Multiple Choice Questionaire
Description
Reinforcement value of cannabis and tobacco as measured by preference for money over the administration of either drug; questionaire has 70 questions and money value vs. drug ranges from 25 cents to 25 dollars 1-70.
Time Frame
collected each day of study
Secondary Outcome Measure Information:
Title
sleep quality
Description
A VAS sleep questionnaire will be used each morning to assess daily sleep quality.
Time Frame
collected on each study day
Title
Neurocognitive Function
Description
The purpose of examining the neurocognitive function of our participants on days 1-4 is to examine the safety of the co-administration of aprepitant at 160 mg/day with oral THC (dronabinol 10 mg) on brain function. Tasks used are the DSST - The Digit Symbol Substitution Test measures the learning of integrating visual and motor skills, and the SRTT- The Simple reaction Time Task is a well validated computerized test for assessing the effects of psychoactive drugs on performance.
Time Frame
collected on days 1-4 of the study
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Description
Blood pressure, pulse, and a Systematic Assessment For Treatment Emergent Events (SAFTEE) are collected daily. Electrocardiograms (EKGs) are collected at baseline and discharge.
Time Frame
each day of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must meet DSM-IV/ICD-10 criteria for cannabis abuse or dependence Must be non-treatment seeking individuals Participant does not meet DSM-IV criteria for any current (i.e., criteria met at any point in the past 30 days) dependence on a substance other than alcohol, nicotine, caffeine, or marijuana or physiological dependence on alcohol requiring medical detoxification. No subjects who have trouble reading the English language or visual or hearing problems that may interfere with the collection of data Not currently taking other medications (with the exception of oral contraceptives) that would preclude safe participation in this study Must test negative for pregnancy prior to inclusion females using birth control pills must agree to use a condom during intercourse for 1 month after participation in study because the study medication will decrease the effectiveness of the birth control pill rendering it ineffective Should be in general good health No evidence of recent use of other illicit drugs on a urine toxicity screen prior to admission Exclusion Criteria: Major current (within last 90 days) Axis I psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia) Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, cancer, epilepsy, kidney disease) Current, repeated illicit drug use (other than marijuana) Subject is breastfeeding or pregnant Concurrent therapy with drugs known to inhibit CYP3A4 activity Request for drug treatment Current parole or probation Recent history of significant violent or suicide behavior Allergic to sesame oil
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather M Haughey, Ph.D.
Organizational Affiliation
University of Virginia School of Medicine, Dept. Psychiatry and Neurobehavioral Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
University of Virginia Center for Addiction Education and Treatment (UVA CARE)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24821356
Citation
Gunderson EW, Haughey HM, Ait-Daoud N, Joshi AS, Hart CL. A survey of synthetic cannabinoid consumption by current cannabis users. Subst Abus. 2014;35(2):184-9. doi: 10.1080/08897077.2013.846288.
Results Reference
derived

Learn more about this trial

Medications Development for the Treatment of Cannabis Related Disorders

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