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Nicotine WithdrawalPhase 1MTCNCT01204723

Medications Development for the Treatment of Cannabis Related Disorders

A Phase 1 study testing Active Aprepitant in people with Nicotine Withdrawal and Marijuana Dependence, run by University of Virginia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Active Aprepitant
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
63 participants
Where
2 sitesUnited States
Study dates
Aug 2009to Apr 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Current parole or probation
  • Recent history of significant violent or suicide behavior
  • Allergic to sesame oil

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Clinical Pharmacological Research Unit (CPRU), University of Virginia School of Medicine

    Charlottesville, Virginia, 22903

  • University of Virginia Center for Addiction Education and Treatment (UVA CARE)

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

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.

Read the 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.

Being tested
Placebo Aprepitant, Active Aprepitant
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
Medical subject headings
Marijuana Abuse, Tobacco Use Disorder, Recurrence, Substance Withdrawal Syndrome, Substance-Related Disorders, Disorders of Environmental Origin, Mental Disorders, Disease Attributes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placebo AprepitantDrug

    Placebo Aprepitant 0 mg once daily for 5 days

  • Active AprepitantDrug

    Active Aprepitant 160 mg once daily for 5 days

Study groups in NCT01204723
Study groupRoleWhat they receive
Behavioral Condition 1ExperimentalNicotine patch (21 mg) plus placebo oral cannabis (0 mg; 3 times a day on days 2-4, given once on day 5)
Receives: Drug: Placebo Aprepitant; Drug: Active Aprepitant
Behavioral Condition 2ExperimentalPlacebo nicotine patch (0 mg) plus oral cannabis (10 mg, 3 times each day, days 2-4, day 5 given once)
Receives: Drug: Placebo Aprepitant; Drug: Active Aprepitant
Behavioral Condition 3ExperimentalPlacebo nicotine patch (0 mg) plus placebo oral cannabis (0 mg, 3 times each day days 2-4, day 5 given once)
Receives: Drug: Placebo Aprepitant; Drug: Active Aprepitant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: collected on each study day

  2. "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)

    Measured: collected on each study day

  3. 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.

    Measured: collected each day of study

Secondary outcomes (3)

  1. sleep quality

    A VAS sleep questionnaire will be used each morning to assess daily sleep quality.

    Measured: collected on each study day

  2. 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.

    Measured: collected on days 1-4 of the study

  3. 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.

    Measured: each day of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2010 (estimated)
  2. Study startAug 2009
  3. Primary completionJan 2012
  4. Study completionApr 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Single group
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01204723
Sponsor's protocol ID
14392
Other IDs
R01DA027131
Acronym
MTC
Status last verified
May 2012
First submitted
14 Sep 2010
Last updated
1 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 24821356

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Active Aprepitant in people with Nicotine Withdrawal and Marijuana Dependence, run by University of Virginia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

withdrawal symptom severity, measured on a 0 (not at all) to 3 (severe) scale (time frame: collected on each study day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204723, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2012.

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