Buspirone, Stress, and Attentional Bias to Marijuana Cues

NCT02132832 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: buspirone, stress, marijuanaR21DA034825
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This project has two primary goals. The first goal is to further scientific understanding about marijuana abuse by examining two recognized factors in marijuana use and relapse: (1) stress/anxiety and (2) atypical reactivity to marijuana-related stimuli (e.g., attentional bias). The second goal is to attenuate the influence of stress/anxiety and attentional bias to marijuana stimuli via administration of buspirone. Buspirone is uniquely suited to this project because it has effects on neurotransmitter systems known to modulate both stress/anxiety and attentional bias.

Conditions

Cannabis Use Disorder

Keywords

marijuana; attentional bias; stress; buspirone

Outcome Measures

Primary Outcomes (12)

• Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements

  Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: \[(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)\]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.

  week 1

• Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements

  Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: \[(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)\]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.

  week 2

• Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements

  Eye movements are analyzed using a MiraMetrix S2 Eyetracker. This outcome measure reports a ratio: \[(number of anti-saccade errors with marijuana-related images) divided by (total number of anti-saccade errors with marijuana-related images or neutral images)\]. Anti-saccade errors are when the subject fails to inhibit fixation onto the image.

  week 3

• Stress as Assessed by the Perceived Stress Scale

  The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.

  week 1

• Stress as Assessed by the Perceived Stress Scale

  The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.

  week 2

• Stress as Assessed by the Perceived Stress Scale

  The Perceived Stress Scale is a 10 item scale that was developed to measure the degree to which individuals appraise their life as stressful and has been widely used in health studies. The scale has a 5-point Likert response format. The total score is calculated by summing responses. The questions are general in nature and relatively content free with regard to specific population groups. The range of scores is 0-40, with 40 indicating the most stress.

  week 3

• Anxiety as Assessed by the Zung Self-Rated Anxiety Scale

  The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80: * 20-44 Normal Range * 45-59 Mild to Moderate Anxiety Levels * 60-74 Marked to Severe Anxiety Levels * 75-80 Extreme Anxiety Levels

  week 1

• Anxiety as Assessed by the Zung Self-Rated Anxiety Scale

  The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80: * 20-44 Normal Range * 45-59 Mild to Moderate Anxiety Levels * 60-74 Marked to Severe Anxiety Levels * 75-80 Extreme Anxiety Levels

  week 2

• Anxiety as Assessed by the Zung Self-Rated Anxiety Scale

  The Zung Self-Rated Anxiety Scale is a widely-used 20 item scale that is scored on a Likert-type scale of 1-4, with 15 questions concerning increasing anxiety levels and five questions concerning decreasing anxiety levels. The scale focuses on the most common general anxiety symptoms and means of coping with stressors that produce anxiety. The range of scores is 20-80: * 20-44 Normal Range * 45-59 Mild to Moderate Anxiety Levels * 60-74 Marked to Severe Anxiety Levels * 75-80 Extreme Anxiety Levels

  week 3

• Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)

  With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question "Please rate your current stress level."

  week 1

• Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)

  With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question "Please rate your current stress level."

  week 2

• Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)

  With the Visual Analogue Stress Scale - Current (VASS-C), current stress level is ranked on a 0 - 10 visual analog scale, with 0 as no stress and 10 as extreme stress, cued by the question "Please rate your current stress level."

  week 3

Study Arms (2)

Buspirone

EXPERIMENTAL

Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.

Drug: Placebo

Interventions

Buspirone DRUG

Buspirone is an anxiolytic compound marked by modulation of both 5-HT1A and D3 receptors. Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.

Buspirone

Placebo DRUG

Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.

Also known as: corn starch

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Marijuana substance use disorder based on a score of ≥ 13 on the Cannabis Use Disorders Identification Test - Revised (CUDIT-R)
• a score of ≥ 4 on the Cannabis Abuse Screening Test (CAST)
• meeting criteria for a marijuana substance use disorder based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV)

You may not qualify if:

• Current DSM-IV Axis I disorder other than marijuana use disorder
• serious medical illness requiring ongoing medical treatment, which could affect the central nervous system, or any other medical contraindication (e.g., renal, cardiovascular, pulmonary, blood) as determined by medical screening
• a positive pregnancy test or breast feeding (females)
• concomitant use of prescription medications that could affect the central nervous system
• active suicidal ideation or Beck Depression Inventory II score greater than 19
• positive urine drug screen for drugs other than marijuana or positive breath alcohol screen
• Shipley-2 test of cognitive aptitude score outside 2 SD units of the published composite score average
• smoking \> 10 nicotine cigarettes per day / Fagerstrom Score \> 4
• taking meds known to have significant drug interactions with buspirone.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Buspirone; Starch

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Limitations and Caveats

The study intends to evaluate reduction of attentional-bias in non-treatment seekers, and it is not designed or powered to address treatment effects on marijuana use.

Results Point of Contact

• Title: Scott D. Lane, PhD
• Organization: The University of Texas Health Science Center at Houston

Scott.D.Lane@uth.tmc.edu

(713) 486-2535

Study Officials

• Scott D. Lane, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 5, 2014
• First Posted: May 7, 2014
• Study Start: June 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: June 2, 2017
• Results First Posted: April 7, 2017

Record last verified: 2017-05

Locations

US (1)