0.08 BAC Alcohol for Hashish Abuse

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hartford Hospital, Hartford, CT
Hashish Abuse+2 More
0.08 BAC Alcohol - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether marijuana and alcohol have a combined effect on driving.

See full description

Eligible Conditions

  • Hashish Abuse
  • Alcohol Impairment
  • Marijuana Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hashish Abuse

Study Objectives

This trial is evaluating whether 0.08 BAC Alcohol will improve 16 primary outcomes and 5 secondary outcomes in patients with Hashish Abuse. Measurement will happen over the course of Baseline and post drug administration at: 30 min; 2.5 hours.

Hour 5
Marijuana and alcohol induced performance changes on Alertmeter.
Marijuana and alcohol induced performance changes on Cogstate 1-back/2-back task.
Marijuana and alcohol induced performance changes on Cogstate Card Learning.
Marijuana and alcohol induced performance changes on Groton Maze Learning task.
Marijuana and alcohol induced performance changes on the ANAM Pursuit Tracking Task.
Marijuana and alcohol induced performance changes on the Cogstate Social/Emotional Cognition Task.
Marijuana and alcohol induced performance changes on the DRUID tasks.
Marijuana and alcohol induced performance changes on the Finger to Nose Task.
Marijuana and alcohol induced performance changes on the Go-No-Go task.
Marijuana and alcohol induced performance changes on the Ipod Balance Task.
Marijuana and alcohol induced performance changes on the Ipod Punching Task.
Marijuana and alcohol induced performance changes on the Line Walking/Months Backwards Task.
Marijuana and alcohol induced performance changes on the One Leg Stand Task.
Marijuana and alcohol induced performance changes on the Ramaeker's Critical Tracking Test.
Marijuana and alcohol induced performance changes on the Time Estimation task.
Marijuana and alcohol induced performance changes on the Time Reproduction Task.
Hour 5
Change in concentration of THC/metabolites in blood samples.
Change in concentration of THC/metabolites in oral fluid tested using Quantisal Oral Fluid Collection devices.
Hour 5
Change in performance on simulated driving Car Following Task.
Change in performance on simulated driving Gap Acceptance Task.
Change in performance on simulated driving Road Tracking Task.

Trial Safety

Safety Progress

1 of 3

Other trials for Hashish Abuse

Trial Design

4 Treatment Groups

Low Dose THC + 0.05 BAC Alc
1 of 4
High Dose THC + 0.05 BAC Alc
1 of 4
Placebo Drug + 0.05 BAC Alc
1 of 4
Placebo Drug + 0.08 BAC Alc
1 of 4
Experimental Treatment

This trial requires 12 total participants across 4 different treatment groups

This trial involves 4 different treatments. 0.08 BAC Alcohol is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Low Dose THC + 0.05 BAC AlcParticipants will receive low dose of THC along with alcohol leading to a BAC of 0.05.
High Dose THC + 0.05 BAC AlcParticipants will receive high dose of THC along with alcohol leading to a BAC of 0.05.
Placebo Drug + 0.05 BAC AlcParticipants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.05.
Placebo Drug + 0.08 BAC AlcParticipants will receive placebo drug with no THC along with alcohol leading to a BAC of 0.08.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2810

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline and post drug administration at: 10 min; 1.5 hours 2.5 hours for reporting.

Who is running the study

Principal Investigator
G. P.
Godfrey Pearlson, Principal Investigator
Yale University

Closest Location

Hartford Hospital - Hartford, CT

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Must have a driver's license; recent 2 years highway driving experience
Cannabis use for at least the past 2 years and report of getting high when smoking cannabis to avoid recruiting novice/inexperienced users.
Reports regularly drinking and smoking (does not need to be at the same time)
Use cannabis at least 5 times within life up to daily use, with occasional day of abstinence with no symptoms of craving or withdrawal.

Patient Q&A Section

What is hashish abuse?

"Hashish abuse, also known as hashish ingestion, is a harmful behaviour linked to the abuse of drugs, particularly cannabis, cocaine, and amphetamine. It is characterized by excessive and often dangerous use." - Anonymous Online Contributor

Unverified Answer

What are the signs of hashish abuse?

"The use of hashish in small quantities is considered addictive, as reflected in the prevalence of hashish abuse. Hashish abusers may exhibit altered consciousness, dizziness, seizures, depression, irritability, hallucinations and paranoid psychosis. Such symptoms may be caused by intoxication or drug withdrawal. The symptoms are also sometimes exacerbated by alcohol or other drugs." - Anonymous Online Contributor

Unverified Answer

What are common treatments for hashish abuse?

"Different strategies are recommended for treatment of hashish abuse. There are no convincing data for propelling the use of psychoactive drugs in modern society. In contrast, the data support a non-medical and non-surgical form of psychosurgery. It is recommended that the psychiatrist first make an attempt at pharmacologic or behavioural methods, and if no satisfactory results are obtained, then proceed to psychosurgical or neurosurgical interventions." - Anonymous Online Contributor

Unverified Answer

Can hashish abuse be cured?

"Many marijuana abusers suffer a severe bout or series of severe bouts of paranoia, anxiety, and depression. They are often addicted to LSD and occasionally to PCP and amphetamines. Marijuana addiction is cured only when the user accepts the fact that marijuana is not the best medicine for his or her problem, and this usually takes several years. A short bout of LSD or amphetamines can often be used to abort a severe cannabis-induced paranoid reaction. Cannabis use by itself can induce severe psychosis. This fact was not mentioned by any of the psychotherapists." - Anonymous Online Contributor

Unverified Answer

How many people get hashish abuse a year in the United States?

"About 0.9 million persons between age 1 and 35 years have reported hashish abuse at least once in the past year. This represents 1.1% of U.S. persons aged 1 to 35 years. However, of those persons who have reported hashish abuse, 4.3% believe that they have used hashish in the past month. This results in hashish use in about three quarters of those who say they use hashish in the past month. However, the prevalence of hashish use among those who report hashish use in the past month remains largely unknown. These data highlight the need for improved health services aimed at the prevention of alcohol use and the reduction of risk behaviour for drug involvement among adolescents." - Anonymous Online Contributor

Unverified Answer

What causes hashish abuse?

"Hashish abuse seems to have its roots in multiple factors. However, hashish abuse is commonly conceptualized as being an internal urge that people are unable to resist. It is believed that this inclination may result from a genetic susceptibility." - Anonymous Online Contributor

Unverified Answer

How does 0.08 bac alcohol work?

"Results show that drinking alcohol does not produce a more relaxed or comfortable state of mind, and may even produce an opposite effect. The alcohol may cause a heightened anxiety-stress response, resulting in a greater desire to move about and to initiate sexual activity, and also to become irritable and prone to tantrums and physical aggression." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets hashish abuse?

"There is a significant difference between gender and average age hashish abusers first start smoking or drinking. The higher the age at which these behaviors start, there will be greater harm done on the kidneys by hashish abuse." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating hashish abuse?

"Hashish may be a legitimate recreational addiction but in this study, there seems to be no effective treatment. Results from a recent paper have not yet been published. However, there seems to be some potential: a study showed that using "Passiflora incarnata" and "Passiflora malincana" in conjunction with an E.C.A. was efficacious in reducing acute cannabis abuse." - Anonymous Online Contributor

Unverified Answer

Does hashish abuse run in families?

"Results from a recent paper provides some evidence for a familial pattern of adolescent hashish abuse, with higher frequency of marijuana use during the same period. There was no correlation between the frequency of current marijuana usage and age at first marijuana use." - Anonymous Online Contributor

Unverified Answer

What is the latest research for hashish abuse?

"Although hashish (and cannabis) consumption is a social issue with significant consequences for health, current knowledge about hashish abuse among people who have been diagnosed with mental disorders is limited to anecdotal information only. Therefore, there is limited knowledge on the most recent research on hashish use." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving 0.08 bac alcohol?

"[Most of the (0.08 % alcohol) studies in which patients participated were of low or moderate methodological quality according to the Cochrane Handbook] (http://wwwnsm.org.au/publication_handbooks/cochranehandbook/2008/02_CochraneHandbook_Part1/CochraneHandbook-Part1.pdf). These shortcomings are similar to those found in previous studies in which patients participated, highlighting the need to improve the methodological rigor of all clinical trials involving alcohol. Patients should carefully consider the health and social circumstances of their condition, weigh the risks and potential benefits of a specific study and consult with their healthcare professional before participating." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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