Cannabis Use DisorderPhase 2NCT02132832
Buspirone, Stress, and Attentional Bias to Marijuana Cues
A Phase 2 study testing Buspirone in people with Cannabis Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Cannabis Use Disorder
- What is being tested?
- Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Mar 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center - Houston
Houston, Texas, 77030
About this study
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.
Read the detailed description
For nearly 40 years marijuana has remained the most widely used illicit drug in the US, with more than 50% of first-time users < age 18. Marijuana accounts for ≈ 60% of illicit substance use disorders (SUD) in the US, bearing by percent the largest US public health burden among illicit substances. Across preclinical, human laboratory, and clinical interview data, there is compelling evidence that the phenomenon of cue reactivity is related to drug seeking and relapse. Attentional bias is a measurable component of cue reactivity, and can be operationally defined as differential attention (e.g., reaction time difference) towards drug-related stimuli vs. neutral stimuli. This phenomenon has been demonstrated in SUD populations across many classes of abused drugs, including alcohol, nicotine, stimulants, opiates, and - importantly - marijuana. Cue reactivity and attentional bias are exacerbated by acute and chronic stress and anxiety. Notably, stress is a well-documented predictor of marijuana abuse and marijuana relapse. Therapeutic interventions that attenuate attentional bias to marijuana cues are a potentially important component in the treatment of marijuana SUD. Due to the well-documented association with stress, an intervention that simultaneously addresses both stress and attentional bias could be uniquely efficacious. Currently, few pharmacotherapies exist for marijuana SUD, and none are presently known to address attentional bias to marijuana cues. This application will explore the potential of the anxiolytic buspirone to modify attentional bias and stress. Buspirone is a unique compound marked by modulation of both serotonin (5-HT1A) and dopamine D3 receptors. Importantly, the 5-HT1A receptor is known to play a key role in stress related anxiety, and preclinical work indicates that D3 antagonists significantly decrease cue reactivity to a number of abused drugs. This combination of effects suggests buspirone may be advantageous in targeting both stress and attentional bias as factors that contribute to problem marijuana use.
Accordingly, this project seeks to examine the effects of chronic buspirone administration on attentional bias and stress/anxiety in marijuana SUD. Using laboratory-based methodologies sensitive to attentional bias towards marijuana cues and well validated measures of stress and anxiety, we will examine if buspirone's unique mechanism of action will (a) produce an attenuation of attentional bias to marijuana cues, and (b) be most pronounced under conditions in which attentional bias is related to high levels of stress and anxiety.
- Conditions
- Cannabis Use Disorder
- Being tested
- Buspirone, Placebo
- Keywords
- marijuana, attentional bias, stress, buspirone
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuspironeDrug
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.
PlaceboDrug
Also called corn starch
Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Buspirone |
| Placebo | Placebo comparator | Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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."
Measured: 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."
Measured: 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."
Measured: week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startJun 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cannabis Use DisorderStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Scott Lane, The University of Texas Health Science Center, Houston
- Investigators
- Scott D. Lane, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132832
- Sponsor's protocol ID
- buspirone, stress, marijuana
- Other IDs
- R21DA034825
- Status last verified
- May 2017
- First submitted
- 5 May 2014
- Last updated
- 2 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buspirone, Stress, and Attentional Bias to Marijuana Cues
- ClinicalTrials.gov ID
- NCT02132832
- Acronym / sponsor ID
- buspirone, stress, marijuana
- Conditions
- Cannabis Use Disorder
- Keywords
- marijuana, attentional bias, stress, buspirone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For nearly 40 years marijuana has remained the most widely used illicit drug in the US, with more than 50% of first-time users < age 18. Marijuana accounts for ≈ 60% of illicit substance use disorders (SUD) in the US, bearing by percent the largest US public health burden among illicit substances. Across preclinical, human laboratory, and clinical interview data, there is compelling evidence that the phenomenon of cue reactivity is related to drug seeking and relapse. Attentional bias is a measurable component of cue reactivity, and can be operationally defined as differential attention (e.g., reaction time difference) towards drug-related stimuli vs. neutral stimuli. This phenomenon has been demonstrated in SUD populations across many classes of abused drugs, including alcohol, nicotine, stimulants, opiates, and - importantly - marijuana. Cue reactivity and attentional bias are exacerbated by acute and chronic stress and anxiety. Notably, stress is a well-documented predictor of marijuana abuse and marijuana relapse. Therapeutic interventions that attenuate attentional bias to marijuana cues are a potentially important component in the treatment of marijuana SUD. Due to the well-documented association with stress, an intervention that simultaneously addresses both stress and attentional bias could be uniquely efficacious. Currently, few pharmacotherapies exist for marijuana SUD, and none are presently known to address attentional bias to marijuana cues. This application will explore the potential of the anxiolytic buspirone to modify attentional bias and stress. Buspirone is a unique compound marked by modulation of both serotonin (5-HT1A) and dopamine D3 receptors. Importantly, the 5-HT1A receptor is known to play a key role in stress related anxiety, and preclinical work indicates that D3 antagonists significantly decrease cue reactivity to a number of abused drugs. This combination of effects suggests buspirone may be advantageous in targeting both stress and attentional bias as factors that contribute to problem marijuana use.
Accordingly, this project seeks to examine the effects of chronic buspirone administration on attentional bias and stress/anxiety in marijuana SUD. Using laboratory-based methodologies sensitive to attentional bias towards marijuana cues and well validated measures of stress and anxiety, we will examine if buspirone's unique mechanism of action will (a) produce an attenuation of attentional bias to marijuana cues, and (b) be most pronounced under conditions in which attentional bias is related to high levels of stress and anxiety.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buspirone | Experimental | Drug: BuspironeBuspirone 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BuspironeBuspirone 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. | Drug | Buspirone |
| PlaceboAlso: corn starchPlacebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. | Drug | Placebo |
Primary outcome
Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements
Time frame: week 1
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.
Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements
Time frame: week 2
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.
Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements
Time frame: week 3
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.
Stress as Assessed by the Perceived Stress Scale
Time frame: week 1
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.
Stress as Assessed by the Perceived Stress Scale
Time frame: week 2
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.
Stress as Assessed by the Perceived Stress Scale
Time frame: week 3
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.
Anxiety as Assessed by the Zung Self-Rated Anxiety Scale
Time frame: week 1
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
Anxiety as Assessed by the Zung Self-Rated Anxiety Scale
Time frame: week 2
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
Anxiety as Assessed by the Zung Self-Rated Anxiety Scale
Time frame: week 3
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
Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)
Time frame: week 1
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."
Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)
Time frame: week 2
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."
Stress as Assessed by the Visual Analogue Stress Scale-Current (VASS-C)
Time frame: week 3
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."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cannabis Use Disorder
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingObservational study
Study of an Oral Fluid Testing Approach
Cannabis Use, Cannabis Intoxication
Active, not recruitingPhase 1
Psilocybin-assisted Treatment for Cannabis Use Disorder
Cannabis Use Disorder
RecruitingObservational study
Assessing Benefits and Harms of Cannabis/Cannabinoid Use Among Cancer Patients Treated in Community Oncology Clinics
Breast Carcinoma, Colorectal Carcinoma
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott D. Lane, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buspirone in people with Cannabis Use Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attentional Bias to Marijuana Specific Stimuli Measured Via Analysis of Eye Movements (time frame: week 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2017.