NCT01179425

Brief Summary

The purpose of this study is to explore sex differences in cognitive functioning and responses to marijuana-related items, and to determine whether stress impacts these measures. Hypothesis 1: Attentional bias will be greater for marijuana cues in male marijuana-dependent subjects relative to female marijuana-dependent or non-dependent male controls. Hypothesis 2: Marijuana-dependent females will exhibit greater stress-induced changes in attentional bias and cognitive functioning than marijuana-dependent males.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

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, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 17, 2009

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 11, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 14, 2011

Status Verified

April 1, 2011

Enrollment Period

1.5 years

First QC Date

November 17, 2009

Last Update Submit

April 13, 2011

Conditions

Keywords

marijuanadependencecognitionstress

Outcome Measures

Primary Outcomes (1)

  • Primary outcome measures will be obtained from the auditory odd-ball task: differences while viewing the marijuana vs neutral video in reaction time (msec), errors of omission (%), and errors of commission (%).

    ~ 3 hours

Secondary Outcomes (1)

  • Secondary measures include subjective (craving and stress), physiological (heart rate and skin conductance), and stress hormone level (cortisol) assessments.

    ~ 3 hours

Study Arms (2)

non-marijuana dependent controls

ACTIVE COMPARATOR
Other: Cognitive stressor

Marijuana-dependent subjects

EXPERIMENTAL
Other: Cognitive stressor

Interventions

The Paced Auditory Serial Addition Task (PASAT-C), has been modified for use as a computerized laboratory-based stressor. Single digits are presented, and the patient must add each new digit to the one immediately prior to it and click on the appropriate answer. Failure to do so in the allotted time results in a noxious error sound.

Marijuana-dependent subjectsnon-marijuana dependent controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Current depression
  • Bipolar disorder
  • Attention deficit hyperactivity disorder
  • History of psychosis
  • Suicidal or homicidal intent
  • Significant cognitive deficits
  • Dependence on any substance other than marijuana, nicotine, or caffeine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina, Dept. of Psychiatry/Clinical Neuroscience Division

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Kimber L Price, PhD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 17, 2009

First Posted

August 11, 2010

Study Start

August 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 14, 2011

Record last verified: 2011-04

Locations