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The Effect of Prescription Medications in Marijuana Users

Primary Purpose

Marijuana Abuse

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dronabinol 30mg/day
Dronabinol 60mg/day
Dronabinol 120mg/day
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Marijuana Abuse focused on measuring withdrawal, acute effects, cognitive performance, Marijuana Use, Marijuana Abstinence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • current use of marijuana
  • able to give informed consent

Exclusion Criteria:

  • dependence on drug other than marijuana
  • 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

  • Behavioral Pharmacology Research Unit

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

0, 30, 60, and 120mg dronabinol

Arm Description

0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing

Outcomes

Primary Outcome Measures

Peak Effect of Marijuana Withdrawal
Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).
Subjective "Drug Effect" After Smoked Marijuana
Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect

Secondary Outcome Measures

Heart Rate
Heart rate measured after acute cannabis exposure

Full Information

First Posted
April 30, 2009
Last Updated
August 2, 2017
Sponsor
Johns Hopkins University
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00893074
Brief Title
The Effect of Prescription Medications in Marijuana Users
Official Title
The Effect of Prescription Medications in Marijuana Users
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A subset of heavy marijuana users have trouble quitting marijuana use and the number of those seeking treatment for problems related to marijuana is increasing. The purpose of this research study is to investigate whether dronabinol can reduce withdrawal effects associated with stopping marijuana use, if dronabinol can reduce the rewarding effects of smoked marijuana, and whether there are any cognitive performance deficits associated with dronabinol doses that produce such effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Abuse
Keywords
withdrawal, acute effects, cognitive performance, Marijuana Use, Marijuana Abstinence

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Within-subjects cross-over evaluation of 0, 30, 60, and 120mg dronabinol per day on withdrawal, cognitive performance, and response to acute cannabis exposure
Masking
ParticipantOutcomes Assessor
Masking Description
Dronbinol doses were double blind and placebo controlled
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0, 30, 60, and 120mg dronabinol
Arm Type
Other
Arm Description
0, 30, 60, and 120mf dronabinol was administered in a randomized within-subjects crossover study to compare the medication dose effects of cannabis withdrawal, cognitive performance, and response to acute cannabis dosing
Intervention Type
Drug
Intervention Name(s)
Dronabinol 30mg/day
Other Intervention Name(s)
THC, Marinol
Intervention Description
10mg dronabinol administered 3x/day for 5 days
Intervention Type
Drug
Intervention Name(s)
Dronabinol 60mg/day
Other Intervention Name(s)
THC, Marinol
Intervention Description
20mg dronabinol administered 3x/day for 5 days
Intervention Type
Drug
Intervention Name(s)
Dronabinol 120mg/day
Other Intervention Name(s)
THC, Marinol
Intervention Description
40mg dronabinol administered 3x/day for 5 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo dronabinol administered 3x/day for 5 days
Primary Outcome Measure Information:
Title
Peak Effect of Marijuana Withdrawal
Description
Total withdrawal based on a composite score of the Marijuana Withdrawal Checklist (range 0-32; higher scores indicate greater withdrawal).
Time Frame
Day 5 of the Dronabinol abstinence period
Title
Subjective "Drug Effect" After Smoked Marijuana
Description
Subjective drug effects on a 100mm point Visual Analog Scale reported following acute cannabis dose administration during dronabinol maintenance, scale ranging 0-100, with 0 being no effect and 100 being maximum effect
Time Frame
Day 5 of the Dronabinol abstinence period
Secondary Outcome Measure Information:
Title
Heart Rate
Description
Heart rate measured after acute cannabis exposure
Time Frame
Assessed on Day 5 of dronabinol maintenance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 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 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
Behavioral Pharmacology Research Unit
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22921474
Citation
Vandrey R, Stitzer ML, Mintzer MZ, Huestis MA, Murray JA, Lee D. The dose effects of short-term dronabinol (oral THC) maintenance in daily cannabis users. Drug Alcohol Depend. 2013 Feb 1;128(1-2):64-70. doi: 10.1016/j.drugalcdep.2012.08.001. Epub 2012 Aug 22.
Results Reference
result
PubMed Identifier
29689485
Citation
Schlienz NJ, Lee DC, Stitzer ML, Vandrey R. The effect of high-dose dronabinol (oral THC) maintenance on cannabis self-administration. Drug Alcohol Depend. 2018 Jun 1;187:254-260. doi: 10.1016/j.drugalcdep.2018.02.022. Epub 2018 Apr 17.
Results Reference
derived
PubMed Identifier
25220020
Citation
Lee D, Vandrey R, Mendu DR, Murray JA, Barnes AJ, Huestis MA. Oral fluid cannabinoids in chronic frequent cannabis smokers during ad libitum cannabis smoking. Drug Test Anal. 2015 Jun;7(6):494-501. doi: 10.1002/dta.1718. Epub 2014 Sep 14.
Results Reference
derived
PubMed Identifier
23831756
Citation
Lee D, Vandrey R, Milman G, Bergamaschi M, Mendu DR, Murray JA, Barnes AJ, Huestis MA. Oral fluid/plasma cannabinoid ratios following controlled oral THC and smoked cannabis administration. Anal Bioanal Chem. 2013 Sep;405(23):7269-79. doi: 10.1007/s00216-013-7159-8. Epub 2013 Jul 6.
Results Reference
derived

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The Effect of Prescription Medications in Marijuana Users

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