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The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

Primary Purpose

Marijuana Dependence

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eszopiclone
Placebo
ramelteon
zolpidem
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Marijuana Dependence focused on measuring marijuana, cannabis, dependence, withdrawal

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • current use of marijuana
  • able to give informed consent

Exclusion Criteria:

  • dependence on drug other than marijuana
  • current sleep disorder
  • pregnant, breast feeding, or planning to become pregnant within the next 3 months
  • currently seeking treatment for cannabis-related problems or otherwise trying to reduce use
  • use of cannabis under the guidance of a physician for a medical disorder
  • unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina)
  • allergy to study medication

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Active Medication

Placebo

Arm Description

Participants receive active hypnotic medication prior to sleep

Participants receive placebo prior to sleep

Outcomes

Primary Outcome Measures

Marijuana Withdrawal

Secondary Outcome Measures

Objective Sleep Assessment
Cognitive Performance

Full Information

First Posted
April 30, 2009
Last Updated
December 3, 2013
Sponsor
Johns Hopkins University
Collaborators
Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00893269
Brief Title
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Official Title
The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
Food and Drug Administration (FDA), National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Heavy marijuana users report experiencing trouble sleeping when they try to quit, but this has not been carefully studied. This research is being done to learn more about sleep function in heavy marijuana users, and to determine whether a medication approved for treating insomnia can help restore normal sleep function during brief periods of abstinence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
marijuana, cannabis, dependence, withdrawal

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Medication
Arm Type
Experimental
Arm Description
Participants receive active hypnotic medication prior to sleep
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive placebo prior to sleep
Intervention Type
Drug
Intervention Name(s)
eszopiclone
Intervention Description
Oral capsule at dose recommended for adults
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Participants receive placebo prior to sleep
Intervention Type
Drug
Intervention Name(s)
ramelteon
Intervention Description
ramelteon
Intervention Type
Drug
Intervention Name(s)
zolpidem
Intervention Description
zolpidem
Primary Outcome Measure Information:
Title
Marijuana Withdrawal
Time Frame
Every day during study participation
Secondary Outcome Measure Information:
Title
Objective Sleep Assessment
Time Frame
Every day during study participation
Title
Cognitive Performance
Time Frame
Every day during study participation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: current use of marijuana able to give informed consent Exclusion Criteria: dependence on drug other than marijuana current sleep disorder pregnant, breast feeding, or planning to become pregnant within the next 3 months currently seeking treatment for cannabis-related problems or otherwise trying to reduce use use of cannabis under the guidance of a physician for a medical disorder unstable or uncontrolled cardiovascular disease (e.g., hypertension, angina) allergy to study medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Vandrey, Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21359104
Citation
Vandrey R, Umbricht A, Strain EC. Increased blood pressure after abrupt cessation of daily cannabis use. J Addict Med. 2011 Mar;5(1):16-20. doi: 10.1097/ADM.0b013e3181d2b309.
Results Reference
derived
PubMed Identifier
21296508
Citation
Vandrey R, Smith MT, McCann UD, Budney AJ, Curran EM. Sleep disturbance and the effects of extended-release zolpidem during cannabis withdrawal. Drug Alcohol Depend. 2011 Aug 1;117(1):38-44. doi: 10.1016/j.drugalcdep.2011.01.003. Epub 2011 Feb 5.
Results Reference
derived

Learn more about this trial

The Effect of Marijuana and Prescription Medications in Mood, Performance and Sleep

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