NCT00374127

Brief Summary

The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 8, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
9.1 years until next milestone

Results Posted

Study results publicly available

September 1, 2017

Completed
Last Updated

September 1, 2017

Status Verified

July 1, 2017

Enrollment Period

3.7 years

First QC Date

September 7, 2006

Results QC Date

August 3, 2017

Last Update Submit

August 3, 2017

Conditions

Marijuana Dependence

Keywords

MarijuanaComparison between joints and bluntsPharmacokinetic effects

Outcome Measures

Primary Outcomes (1)

  • Plasma THC

    Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.

    180 minutes

Secondary Outcomes (4)

  • Subjective Effects on MRF

    180 minutes

  • Subjective Effects on VAS

    180 minutes

  • Carbon Monoxide

    180 minutes

  • Heart Rate

    180 minutes

Study Arms (2)

marijuana blunt

EXPERIMENTAL

marijuana blunt (0%, 1.8%, or 3.6% THC)

Drug: Marijuana blunt

marijuana cigarette

EXPERIMENTAL

marijuana cigarette (0%, 1.8%, or 3.6% THC)

Drug: marijuana cigarette

Interventions

Marijuana bluntDRUG

Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg).

Also known as: Blunt
marijuana blunt
marijuana cigaretteDRUG

Marijuana cigarettes were provided by the National Institute on Drug Abuse.

Also known as: Joint
marijuana cigarette

Eligibility Criteria

Age21 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current blunt marijuana use (minimum of twice/week) drug screen
  • years of age
  • Practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

You may not qualify if:

  • Current, repeated illicit drug use(excluding marijuana)
  • Heavy cigarette use (\> 10 cigarettes/day)
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension)
  • Laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP \> 140/90; hematocrit \< 34 for women, \< 36 for men)
  • Significant adverse reaction to marijuana
  • Current parole or probation
  • Pregnancy or current lactation
  • History of significant violent behavior
  • Major current Axis I psychopathology(e.g., mood disorder with functional impairment or suicide risk, anxiety disorder, schizophrenia)
  • History of heart disease
  • Current use of any over-the-counter or prescription

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

It is unknown if the cigar paper would provide physiologically relevant nicotine plasma levels under more extended durations of smoking. The small sample size prohibited an analysis to verify a statistically significant sex difference.

Results Point of Contact

Title
Dr. Meg Haney, Professor of Neurobiology
Organization
New York State Psychiatric Institute at Columbia University Medical Center
meg.haney@nyspi.columbia.edu
6467746153

Study Officials

  • Margaret Haney, Ph.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

December 1, 2004

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 1, 2017

Results First Posted

September 1, 2017

Record last verified: 2017-07

Locations

US(1)