Ph1 Marinol Interaction Study - Part 1 - 1 | NCT00438139

Studies
Ph1 Marinol Interaction Study - Part 1 - 1

NCT00438139

Sponsor

National Institute on Drug Abuse (NIDA)

Status

Terminated

Last Update Posted

Jan 16, 2017Estimated

Enrollment

Phase

Phase 1

Conditions

Marijuana Dependence

Interventions

Dronabinol

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Feb 20, 2007

First Submission Date that Met QC Criteria

Feb 20, 2007

First Posted Date

Feb 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2017

Last Update Posted Date

Jan 16, 2017Estimated

Description Module

Brief Summary

The purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Dronabinol	Drug

Measure	Description	Time Frame
Cardiovascular responses

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be between the ages of 18 to 45 years of age
Must be in good general health
Must meet DSM-IV criteria for marijuana dependence and are non- treatment seekers at the time of study
Must be able to provide written informed consent
Must be able to provide 1 marijuana positive urine specimen (> 50 ng/mL) within the 28-day screening period
If female and of child bearing potential, must agree to use birth control.

Exclusion

Criteria:

Please contact site for more information.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Louis Cantilena, M.D.	Uniformed Services University of Health Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uniformed Services University of Health Science		Bethesda	Maryland	20814 4799	United States

Condition Browse Module

MeSH Terms

ID	Term
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D019966	Substance-Related Disorders
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013759	Dronabinol

Ancestor Terms

ID	Term
D002186	Cannabinoids
D013729	Terpenes
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided