Sex Differences in Attentional Bias in Marijuana-dependent Individuals

Marijuana Dependence Clinical Trial

Official title:

Sex Differences in Attentional Bias and Cognitive Functioning in Response to Stress in Marijuana-dependent Individuals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01179425
• Other study ID #: HR# 19292
• Status: Completed
• Phase: N/A
• First received: November 17, 2009
• Last updated: April 13, 2011
• Start date: August 2009
• Est. completion date: February 2011

Study information

• Verified date: April 2011
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina, Dept. of Psychiatry/Clinical Neuroscience Division	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Secondary measures include subjective (craving and stress), physiological (heart rate and skin conductance), and stress hormone level (cortisol) assessments.		~ 3 hours	No