Sex Differences in Attentional Bias in Marijuana-dependent Individuals

This study has been completed.
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01179425
First received: November 17, 2009
Last updated: April 13, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention
Marijuana Dependence
Other: Cognitive stressor

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sex Differences in Attentional Bias and Cognitive Functioning in Response to Stress in Marijuana-dependent Individuals

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • 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 (%). [ Time Frame: ~ 3 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary measures include subjective (craving and stress), physiological (heart rate and skin conductance), and stress hormone level (cortisol) assessments. [ Time Frame: ~ 3 hours ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: non-marijuana dependent controls Other: Cognitive stressor
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.
Experimental: Marijuana-dependent subjects Other: Cognitive stressor
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.

Detailed Description:

Ample evidence implicates both environmental cues and negative affective states in maintaining drug use or triggering relapse. However, although 'craving' is believed to drive continued drug use, it is not well understood how cognitive processes influence craving and relapse, nor how they may differ between the sexes. Therefore, the goal of this study protocol is to provide insight into sex differences in the cognitive aspects of drug craving and to assess the impact of stress on attentional bias for drug-related cues as well as on the availability of cognitive resources.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria will include subjects between the ages of 18-65 who meet full DSM-IV criteria for marijuana dependence and non-dependent controls.

Exclusion Criteria:

  • Exclusion criteria will include medications that may affect cognitive or HPA-axis functioning
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01179425

Locations
United States, South Carolina
Medical University of South Carolina, Dept. of Psychiatry/Clinical Neuroscience Division
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Kimber L Price, PhD Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Kimber L. Price, Ph.D., Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01179425     History of Changes
Other Study ID Numbers: HR# 19292
Study First Received: November 17, 2009
Last Updated: April 13, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
marijuana
dependence
cognition
stress

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 20, 2014