CBD Oil And Methadone

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CBD Oil And Methadone The widespread use of heroin and prescription opioids in the United States during the past decade has resulted in an unprecedented epidemic of opioid addiction, and few Safety of Cannabidiol Given to Subject With Methadone or Buprenorphine The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid

CBD Oil And Methadone

The widespread use of heroin and prescription opioids in the United States during the past decade has resulted in an unprecedented epidemic of opioid addiction, and few treatments for heroin use disorders are currently available. In this study, authors conducted a clinical trial to test whether cannabidiol (CBD), a non-intoxicating cannabinoid that is found in the cannabis plant, could reduce drug craving and anxiety in recently-abstinent individuals with heroin use disorder. The study found that, compared to those who received a placebo, individuals who received a dose of CBD medication showed a reduction in craving for heroin as well as reduced anxiety, which lasted for about a week after taking the CBD medication.

WHAT PROBLEM DOES THIS STUDY ADDRESS?

In the past decade, there has been an unprecedented spike in opioid use disorde r , which has led to more than 300,000 opioid-related deaths in the United States . O pioid use disorder medications such as methadone and buprenorphine (often prescribed in a formulation with naloxone , known by the brand name S uboxone ) help reduce opioid use and reduce risk for opioid-involved overdoses . In some areas, however, t hese medications are often underutilized and therefore can be difficult to access, creating a treatment gap in which those who need medications face barriers to actually receiving them. Further, 20-40% of opioid use disorder patients do not want to take agonist treatments .

One of the hypothesized factors contributing to these barriers is that methadone and Suboxone can be misused or diverted because they can produce euphoria . Consequently, discovering effective alternative medications that can also treat opioid use disorder that circumvent concerns about their psychoactive properties could help more of those affected . To address this problem , the authors investigated whether the cannabinoid , CBD , which is thought to be safe and non-addictive, could be useful in the treatment of opioid use disorder .

HOW WAS THIS STUDY CONDUCTED?

This was a randomized clinical trial with 42 participants who received one of two different CBD medication doses or a placebo once daily for 3 days and were then exposed to drug-related or neutral cues to see whether CBD could reduc e opioid cravings and anxiety – factors strongly associated with relapse to opioid use .

Participants were recruited through advertisements. Most participants indicated preference for intranasal heroin use, most reported currently using more than 10 bags of heroin (one bag = 1 g) daily, and on average, participants had been using heroin for over 10 years. The majority of participants (64.3%) had been abstinent from heroin use for less than 1 month.

The study medication used in this study, EPIDIOLEX, is a n FDA-approved medication that is dispensed through a pharmacy (not to be confused with “medical marijuana , ” which is comprised of a wide variety of non- federally- regulated cannabis projects ) . EPIDIOLEX is a plant-derived CBD liquid formation. P articipants were randomly assigned to receive 400 mg of CBD, 800 mg of CBD, or a placebo medication. CBD or placebo was administered once daily for 3 days . In addition to measuring the effect of the medication on opioid craving, anxiety, the authors also collected measures of positive and negative emotions, vital signs (skin temperature, blood pressure, heart rate, respiratory rate), and salivary cortisol levels , which measure stress response.

At three time points – immediately after the CBD or placebo administration ; 24 hours after the CBD or placebo administration ; and 7 days after the third and final CBD or placebo administration – p articipants were exposed to drug – related and neutral cues . The 3-minute neutral cue condition consisted of a video showing relaxing scenarios, such as scenes in nature. The drug cue condition was a 3-minute video that showed intravenous or intranasal drug use, depending on the participant’s reported preferred route of drug use . Immediately after the presentation of the videos , participants were also exposed to neutral objects or to heroin – related paraphernalia (e.g., syringe, rubber tie, and packets of powder resembling heroin) for 2 minutes. Authors examined whether patients who received CBD, compared to those who received placebo, showed differences in opioid craving, anxiety, positive and negative emotions, or vital signs , after being exposed to the drug or neutral cues.

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WHAT DID THIS STUDY FIND?

I ndividuals receiving the non-psychoactive cannabinoid CBD medication reported less craving after being exposed to drug cues compared with i ndividuals receiving placebo . This effect lasted at least a week after the CBD or placebo administration, when i ndividuals receiving the high-dose of CBD (but not the low-dose) still reported less craving compared with those receiving placebo . In addition, CBD reduced measures of stress response after the drug cue – such as heart rate and salivary cortisol increases . I ndividuals receiving CBD reported less anxiety after being exposed to drug cues compared with i ndividuals receiving placebo (though t here w ere no significant difference s in anxiety between participants receiving the low-dose vs . the high-dose of CBD ) . There was no effect of CBD on positive affect or on any cognitive measures.

Figure 1. Figure 2. Figure 3.

WHAT ARE THE IMPLICATIONS OF THE STUDY FINDINGS?

In light of the opioid epidemic, it is important to identify as many strategies as possible to curb opioid addiction. In the past few years, scientists have asked whether or not cannabis use can help individuals recover from opioid use disorder or may serve as a less-risky pain management approach to pharmaceutical opioids . Individuals also report using cannabinoids in an effort to cut back or quit other substances , but currently, data do not support this indication. Some studies have shown no benefit; in fact, studies have shown that cannabis use is related to greater odds of both new-onset opioid use and opioid use disorder 3 years later . The small, experimental study here shows a potential benefit of CBD in reduc ing cue-induced craving and anxiety in heroin-abstinent individuals . This suggest s a potential role for CBD in relapse prevention of heroin use disorder . T his study takes a more rigorous approach that can serve as a model for future studies of cannabinoids and their potential role in OUD treatment and recovery.

  1. The sample size in this study was very small and , although results are promising, the findings need replication in larger samples. The small sample also did not allow for exploration of sex/gender effects, which could be important given that women typically have higher craving and anxiety than men.
  2. The study medication used in this study, EPIDIOLEX, is a n FDA-approved medication that you can only get from a pharmacy. Though EPIDIOLEX is derived from cannabis, it is NOT medical marijuana . This medication does not contain THC, which is the compound in the cannabis plant that causes the ‘high’ and euphoria. It is therefore important for patients to realize that although benefits of CBD were found, this study does NOT support the use of “medical marijuana” for opioid use disorder.
  3. This study only examined opioid craving for 7 days. It is still unknown if CBD would reduce opioid craving past the 7-day window examined in this study o r whether use of CBD actually translates into less use of actual opioids.
  4. Patients in this study had to be abstinent from opioids, and not taking any agonist therapie s. Therefore, the population in this study r epresent s individuals who are doing well and may respond will to lots of different interventions . However, this population may not be representative of opioid use disorder patients more generally.
BOTTOM LINE
  • For individuals and families seeking recovery: This study showed that compared to placebo the non-psychoactive cannabinoid , CBD , was associated with substantially de creased cue-induced craving and anxiety for those with heroin use disorder . Many individuals with opioid use disorders are seeking alternative treatments to curb cravings and reduce anxiety, and many are reluctant to try agonist treatments such as methadone or suboxone . While more research is needed to flesh out whether CBD increase s the likelihood of long-term abstinence, this study suggests individuals may benefit from EPIDIOLEX, the FDA-approved CBD medication , but more larger studies are needed to confirm this . It is important to note, however, that individuals are using cannabis in its unregulated forms, and legislatures are passing med ical cannabis laws that identify opioid use disorder as one of the conditions for which cannabis is indicated without evidence to support this indication . Consequently, individuals seeking to use cannabis , in general, for opioid addiction should proceed cautiously .
  • Fortreatment professionals and treatment systems: This study showed that compared to placebo, CBD was associated with substantially de creased cue-induced craving and anxiety for those with heroin use disorder . A recent survey found that a considerable percentage (30%) of individuals receiving agonist treatment were worried about encountering negative attitudes related to being prescribed agonists, and only 33% reported their provider discussed this with them prior to attending a meeting . If CBD does pan out as a potential treatment of heroin use disorder, this could appeal to many p atient s, and could be a good complement to recovery support services. It is important for treatment professionals to be aware that the unregulated forms of cannabis, e.g. , those that can be purchased at medical marijuana dispensaries, are still unproven treatments, and may in fact produce more harm than good.
  • For scientists: This study showed that compared to placebo, CBD was associated with substantially de creased cue-induced craving and anxiety for those with heroin use disorder . More w ork is needed that more precisely measures whether CBD increases the likelihood of long-term abstinence , as well as for whom, and under what conditions , this medication work best. Greater knowledge in this regard could inform the nature of medication development more broadly . By pursuing investigation into other alternative treatments for opioid use disorder, scientists may be able to help reduce stigma and improve outcomes for patients with OUD .
  • For policy makers: This study showed that compared to placebo CBD was associated with substantially de creased cue-induced craving and anxiety for those with heroin use disorder . While more research is needed, CBD may be an alternative to other medications for opioid use disorder, which are limited and not well-accessible to racial/ethnic minorities and those without financial means . Policy makers, however, should be aware that this study does not provide evidence that unregulated forms of cannabis, especially those containing THC, help with OUD. F unding research studies that examine pure forms of CBD, and other alternative treatments for opioid use disorder , could help improve outcomes and reduce the public health burden of the current epidemic of opioid addiction .
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CITATIONS

Hurd, Y. L., Spriggs, S., Alishayev , J., Winkel, G., Gurgov , K., Kudrich , C., . . . Salsitz , E. (2019). Cannabidiol for the reduction of cue-induced craving and anxiety in drug-abstinent individuals with heroin use disorder: A double-blind randomized placebo-controlled trial . American Journal of Psy chiatry, ( ePub ahead of print). doi : 10.1176/appi.ajp.2019.18101191

Safety of Cannabidiol Given to Subject With Methadone or Buprenorphine

The overarching goal of this study is to evaluate the potential of Cannabidiol (CBD) as an adjunctive treatment for comorbid opioid use disorder (OUD) and chronic pain. This is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.

Condition or disease Intervention/treatment Phase
Addiction Drug: CBD Day 1 Drug: CBD Day 2 Drug: CBD Day 3 Early Phase 1

An initial safety pilot phase will recruit six participants: three receiving treatment with methadone and three receiving treatment with buprenorphine. If the results of the pilot study support the safety of CBD administration in this clinical sample, the general study will recruit 48 participants with comorbid OUD and chronic pain, for a total of 24 completers – 12 subjects (6 men and 6 women) receiving methadone and 12 subjects (6 men and 6 women) receiving buprenorphine. Both sub-studies will enroll participants who do not currently require an inpatient hospitalization.

Layout table for study information

Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Initial safety pilot phase of 6 participants,(3 methadone and 3 on Buprenorphine) The general study is a randomized, placebo-controlled, crossover human laboratory study investigating the dose-dependent safety and acute effects of CBD on measures of pain and opioid craving in outpatients with OUD receiving medication-assisted treatment (MAT) with methadone or buprenorphine.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cannabidiol Pharmacotherapy for Comorbid Opioid Addiction and Chronic Pain
Actual Study Start Date : December 8, 2021
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : July 30, 2023
    Pain Threshold [ Time Frame: 4 measurements per test day, 3 total test days ]
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The Cold Pressor (CPT measures Pain threshold (in seconds). For this test, a cooler filled with cold water (32.9-34.7degrees F/0.5-1.5 degrees C) are used. Participants are instructed to immerse their hand into the water and report the first time they experience pain (pain threshold). Lower scores indicate lower pain threshold. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.

The Cold Pressor Test (CPT) measures pain threshold and pain tolerance (in seconds). For this test, a water cooler is filled with cold water (32.9-34.7ºF/0.5-1.5ºC) are used. To begin the CPT, Participants are then instructed to immerse their hand into the cold water bath and report when the pain becomes unbearable (pain tolerance). Lower scores indicate lower pain tolerance. Minimum score is 0 seconds, and a maximum cut-off score of 300 seconds is used to prevent tissue damage.

The QST is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience

The QST is a reliable, dynamic, and computerized method of quantifying distinct mechanisms of the pain experience

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information

Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
  • Males and females, Veterans and non-Veterans, aged between 18 and 70 years old.
  • Diagnosed with OUD and currently enrolled in methadone or buprenorphine maintenance treatment.
  • Having chronic pain, uniformly operationalized as grade II (high-intensity) non- cancer pain for ≥ 6 months 49.
  • Capable of providing informed consent in English.
  • Compliant in opioid maintenance treatment and on a stable dose for four weeks or longer.
  • Not meeting DSM-5 criteria for substance use disorders other than OUD or tobacco use disorder within the last 12 months.
  • No current medical problems deemed contraindicated for participation by principal investigator.
  • For women, not pregnant as determined by pregnancy screening; not breast-feeding; using acceptable birth control methods. Acceptable contraception for females includes oral contraceptives, contraceptive depot injections, contraceptive subdermal implants, intrauterine devices, or surgical contraception methods. Acceptable contraception for males includes condoms or surgical contraception methods.
  • Other current major psychiatric disorders deemed clinically unstable by the principal investigator, such as severe depression and/or active suicidal ideation.
  • Having experienced major psychosocial stressors recently (≤ 6 weeks before enrollment), at the discretion of the principal investigator.
  • Methadone dose under 60mg or over 100mg
  • Buprenorphine over 24mg.
  • Having received inpatient psychiatric treatment recently (≤ 60 days before enrollment).
  • Candidates receiving products containing either THC or CBD will be excluded.
  • Current use regular use other prescription opioids, gabapentinoids (pregabalin, gabapentin), antidepressants (SSRIs, SNRIs, TCAs), benzodiazepines, platelet inhibitors (e.g., clopidogrel, apixaban, ticagrelor), or NSAIDs.
  • Current weight of less of 60 kg.
  • Allergy to sesame seed oil, which is an ingredient of the CBD formulation used.
  • Serious medical or neurological illness or treatment for a medical disorder that could interfere with study participation as determined by principal investigator.
  • Participants who have elevation of liver enzymes (ALT and/or AST) 2x above the normal limit or higher.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05076370

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