NCT00373503

Brief Summary

The purpose of this study is to investigate the interaction between marijuana and two potential treatment medications: lofexidine and oral THC, with the direct goal of using this information to improve marijuana treatment outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2005

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

August 1, 2005

Completed
1.1 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
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

February 5, 2013

Status Verified

February 1, 2013

Enrollment Period

1.8 years

First QC Date

September 7, 2006

Last Update Submit

February 4, 2013

Conditions

Marijuana Dependence

Keywords

LofexidineOral THCCannabinoids

Outcome Measures

Primary Outcomes (1)

  • marijuana relapse

    4 days

Secondary Outcomes (1)

  • marijuana withdrawal symptoms

    3 days

Other Outcomes (1)

  • cardiovascular effects

    7 days

Study Arms (1)

lofexidine, dronabinol, marijuana

EXPERIMENTAL

lofexidine (.6 mg qid), dronabinol (20 mg tid)

Drug: LofexidineDrug: dronabinolDrug: Marijuana

Interventions

LofexidineDRUG

alpha 2 adrenergic agonist, hypothesized to decrease noradrenergic activity

Also known as: Britlofex
lofexidine, dronabinol, marijuana
dronabinolDRUG

cannabinoid agonist hypothesized to decrease MJ withdrawal

Also known as: THC
lofexidine, dronabinol, marijuana
MarijuanaDRUG

marijuana intoxication, withdrawal and relapse assessed

Also known as: cannabis
lofexidine, dronabinol, marijuana

Eligibility Criteria

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

You may qualify if:

  • Current marijuana use: average of 3 marijuana cigarettes at least 4 times per week for the past 4 weeks
  • Able to perform study procedures
  • years of age
  • Women practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)

You may not qualify if:

  • Current, repeated illicit drug use (other than marijuana)
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension, clinically significant laboratory abnormalities)
  • Bradycardia (55 beats/minute), hypotension (\< 90 mmHg) including orthostatic hypotension (\> 20 mmHg decrease in SP, or \> 10 mmHg decrease in DP upon standing
  • History of heart disease
  • Request for drug treatment
  • Current parole or probation
  • Pregnancy or current lactation
  • Recent history of significant violent behavior
  • Major current Axis I psychopathology (e.g., major depressive disorder, bipolar disorder,suicide risk, schizophrenia)
  • Current use of any prescription or over-the-counter medication

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

Interventions

lofexidineDronabinolnabiximols

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Margaret Haney, Ph.D.

    New York State Psychiatric Institute

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 8, 2006

Study Start

August 1, 2005

Primary Completion

June 1, 2007

Study Completion

September 1, 2008

Last Updated

February 5, 2013

Record last verified: 2013-02

Locations

US(1)