Treatment for Hashish Abuse

Phase-Based Estimates
1
Effectiveness
2
Safety
Ucsd Hnrp-Cmcr, San Diego, CA
Hashish Abuse+3 More
Eligibility
18+
All Sexes
Eligible conditions
Hashish Abuse

Study Summary

This study is evaluating whether cannabis may have positive impacts for individuals with HIV.

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Eligible Conditions

  • Hashish Abuse
  • Marijuana Abuse
  • Toxic Encephalitis
  • Neurotoxicity Syndromes
  • Human Immunodeficiency Virus (HIV) Infections
  • Cannabis Use

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 31 primary outcomes and 2 secondary outcomes in patients with Hashish Abuse. Measurement will happen over the course of Up to 5 weeks: baseline to administration visits.

Hour 2
1a iii. Change in ART drug concentrations in blood
1a iv. Change in CSF/plasma ratio of ART drug concentrations
3 to 11 days
1b iii. Comparison between the effects of placebo and THC on ART pharmacokinetics and between the effects of placebo and CBD on ART pharmacokinetics
1b iv. Comparison between the effects of placebo and CBD on the CSF/plasma ratio of ART drug concentrations and between the effects of placebo and THC on the CSF/plasma ratio of ART drug concentrations
1b v. Comparison between the effects of THC and CBD on ART pharmacokinetics.
1b vi. Comparison between the effects of THC and CBD on the CSF/plasma ratio of ART drug concentrations.
2a. Effects of chronic cannabis use on the CSF/serum albumin ratio and P-glycoprotein (P-gp) expression.
2b. Examine the correlation between ART concentration in CSF and blood during placebo treatment compared to THC and CBD administration.
2c. Effects of THC or CBD on uridine 5'-diphospho-glucuronosyltransferase (UGT) activity compared to placebo.
3b i. Effects of cannabis use on the correlation between ART and neurocognitive performance.
3b i. Effects of cannabis use on the relationship between ART and neurocognitive performance.
3b ii. Effects of cannabis use on the correlation between ART and depression.
3b ii. Effects of cannabis use on the relationship between ART and depression.
3b iii. Effects of cannabis use on the correlation between ART and emotional health.
3b iii. Effects of cannabis use on the relationship between ART and emotional health.
3b iv. Effects of cannabis use on the correlation between ART and emotional health.
3b iv. Effects of cannabis use on the relationship between ART and emotional health.
3b v. Effects of cannabis use on the correlation between ART and emotional health.
3b v. Effects of cannabis use on the relationship between ART and emotional health.
3b vi. Effects of cannabis use on the correlation between ART and neurotoxicity.
3b vi. Effects of cannabis use on the relationship between ART and neurotoxicity.
3b vii. Effects of cannabis use on the correlation between ART and neurotoxicity.
3b vii. Effects of cannabis use on the relationship between ART and neurotoxicity.
3b viii. Effects of cannabis use on the correlation between ART and neurotoxicity.
3b viii. Effects of cannabis use on the relationship between ART and neurotoxicity.
5 hours
1b i. Effects of placebo, THC, and CBD on ART drug concentration
1b ii. Effects of placebo, THC and CBD on the CSF/plasma ratio of ART drug concentrations
Cross-sectional; measured before ART ingestion
1a i. Antiretroviral therapy (ART) drug concentration in blood
1a ii. Cerebrospinal fluid (CSF)/plasma ratio of ART drug concentrations
Week 5
3a. i. Associations between CD4+ T-cell count and ART drug concentration.
3a. i. Correlation between CD4+ T-cell count and ART drug concentration.
3a. ii. Associations between HIV DNA and ART drug concentration.
3a. ii. Correlation between HIV DNA and ART drug concentration.

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

3 Treatment Groups

CBD Cannabis
Placebo group

This trial requires 40 total participants across 3 different treatment groups

This trial involves 3 different treatments. Treatment is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

CBD Cannabis
Drug
0.35% THC/ 11.27% CBD
THC Cannabis
Drug
12.13% THC/ 0.09% CBD
Placebo
Drug
≤ 0.01% THC/ ≤ 0.01% CBD

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 to 11 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 3 to 11 days for reporting.

Who is running the study

Principal Investigator
S. L.
Prof. Scott Letendre, Professor
University of California, San Diego

Closest Location

Ucsd Hnrp-Cmcr - San Diego, CA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age 18 or older;
Capacity to provide informed consent;
Presence of HIV infection by a standard diagnostic test;
On a stable ART regimen for at least 3 months;
Taking an ART drug that is metabolized by either cytochrome p450 (CYP) isozymes or by uridine 5'-diphospho-glucuronosyltransferase (UGT) isozymes;
Treatment with an integrase inhibitor (i.e. dolutegravir);
You are willing to refrain from driving or operating heavy machinery after the visit. show original
You are willing to abstain from cannabis for at least 24 hours prior to the Phase 1 assessment. show original
You are willing to abstain from grapefruit juice consumption for 4 weeks prior to the Phase 1 assessment. show original
You have used cannabis in the past two years without a severe adverse reaction. show original

Patient Q&A Section

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

What is hashish abuse?

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Given the popularity of hashish use in the Canadian population, the need for high-quality prevention and intervention programs is highlighted. While many individuals with a history of hashish abuse are aware of their addiction, and are trying to quit, most lack the expertise required to help themselves.

Unverified Answer

What are common treatments for hashish abuse?

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The experience of hashish abuse among medical residents is low. It is recommended that medical schools implement and sustain addiction treatment programs that include instruction on methods to reduce or prevent hashish use.

Unverified Answer

What causes hashish abuse?

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Hashish abuse does not seem to have a clear cause, although the psychological effects of hashish are discussed, including an evolutionary basis. Other than these psychological effects, there is no direct evidence that hashish is a cause of cancer.

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

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The American Psychological Association's latest survey, the first in 30 years, estimated that about 1% of Americans have tried cannabis use before age 30 and 13% at age 20; about 37% of those who ever use cannabis are daily users.

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Can hashish abuse be cured?

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The long-term effects of hashish consumption tend to be as variable as the symptoms that are present before or after exposure to hashish. Hashish consumption, while not an entirely benign experience, does not seem to be an incurable condition, nor a condition which may be cured.

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What are the signs of hashish abuse?

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These signs of hashish abuse include anhedonia, forgetfulness, confusion, hallucinations, increased feelings of anxiety and paranoia, delusions, irritability and depression and a tendency towards violent behaviour. These may be due to a decrease in dopamine and to an increase in serotonin.

Unverified Answer

Does hashish abuse run in families?

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This report reveals a higher frequency of Hashish use and dependence in relatives of subjects with Hashish substance abuse and the possibility of genetic factors being associated with dependence with Hashish. The occurrence of Hashish abuse is similar in familial and non-familial populations (i.e., non-Genealog) for the same amount of Hashish use. Therefore, the prevalence of Hashish addiction seems to be a familial disease. Hashish abuse ran in families most often in a autosomal dominance-like mode. In contrast, the use of cannabis was not associated with a familial risk.

Unverified Answer

Does treatment improve quality of life for those with hashish abuse?

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Treatment does not substantially enhance QOL in subjects with severe HA (QOL-ES, P <.001). These subjects should continue to experience the significant deficits in QOL that they report, given the serious comorbidities and other barriers they experience in obtaining treatment.

Unverified Answer

What is treatment?

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There are both positive and negative effects of cannabinoids. They produce some physiological stimulation of the body and can lead to positive consequences such as euphoria, diminished stress, and increased feelings of happiness. They can also produce other experiences such as dysphoria and anxiety. The combination of different substances leads to greater effects, such as a heightened perception of sensation. However the risks are not always clear-cut. Use of hashish can lead to the potential of intoxication, hallucinations, and paranoia. There are potential cognitive functions and effects such as memory enhancement, cognition, and insight. Use of cannabis may give users the sensation of a higher state of consciousness.

Unverified Answer

What is the latest research for hashish abuse?

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[Hashish abusers are at risk for a variety of negative health conditions which include, but are not limited to, chronic inflammation, poor immune function, and increased risk of developing coronary conditions later in life.] The more the patient smoked [hashish], the higher his risk of getting coronary disease.

Unverified Answer

How serious can hashish abuse be?

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The frequency and seriousness of hashish abuse cases reported in the literature vary widely. There are few studies which describe cases of hashish abuse that resulted in death, suicide, or amputation. This may reflect either inadequate reporting or a lack of interest in this relatively rare and stigmatized disorder.

Unverified Answer

How does treatment work?

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Based on the results of several recent studies with various treatment regimens, it appears that the use of the 5-ASA drugs could beneficially modify the course of MS. However, in spite of the number of studies in different countries, no large control group has been used, resulting in heterogeneity of studies and treatments used by different groups. Therefore, it seems that a large, prospective, randomised, multicentre, double blind, placebo-controlled study is warranted to confirm these findings.

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