Treatment for Cocaine Use Disorders

Phase-Based Estimates
1
Effectiveness
1
Safety
Connecticut Mental Health Center, New Haven, CT
Eligibility
18 - 65
All Sexes
Eligible conditions
Cocaine Use Disorders

Study Summary

This study is evaluating whether vitamin D might help people stop using cocaine.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Treatment will improve 2 primary outcomes and 3 secondary outcomes in patients with Cocaine Use Disorders. Measurement will happen over the course of 15 minutes.

15 minutes
Probabilistic Reward Task (PRT)
Probabilistic Selection Task (PST)
150 minutes
Subjective Effects of Cocaine / Visual Analog Scale (VAS)
90 minutes
Cocaine Self Administration Attempts
Cocaine Self Administration Infusions

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Acute Pretreatment with Placebo
Placebo group

This trial requires 24 total participants across 2 different treatment groups

This trial involves 2 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 < 1 and are in the first stage of evaluation with people.

Acute Pretreatment with Placebo
Other
To explore the effects of acute pre-treatment with placebo on attempts to self-administer and ultimate number of infusions/boluses of cocaine, in experienced, non treatment-seeking users of the drug
Acute Pretreatment with Calcitriol
Drug
To explore the effects of acute pre-treatment with Calcitriol on attempts to self-administer and ultimate number of infusions/boluses of cocaine, in experienced, non treatment-seeking users of the drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 150 minutes
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 150 minutes for reporting.

Who is running the study

Principal Investigator
M. P.
Marc Potenza, Principal Investigator
Yale University

Closest Location

Connecticut Mental Health Center - New Haven, CT

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
DSM-5 criteria for at least moderate Cocaine Use Disorder
Recent street cocaine use in excess of quantities used in the current study
Intravenous and/or smoked (crack/ freebase) use
Age 30-55 years
Voluntary, written, informed consent
Physically healthy by medical history, physical, neurological, ECG and laboratory examinations
Positive urine toxicology screen for cocaine
Laboratory evidence of vitamin D sufficiency (i.e., 25(OH)-vitamin D3 level ≥ 20/mg)
For females, a negative serum pregnancy (HCG) test at screening and admission, and a negative urine pregnancy test (HCG) on cocaine administration days.

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 causes cocaine use disorders?

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Factors associated with cocaine use disorders may also be associated with increased risk for cocaine use. Factors associated with increased risk, as judged by prevalence estimates, include being a male, having a history of alcohol or drug misuse, the use of marijuana at an early age, and the family history of antisocial personality disorder. Factors associated with increased risk based on prevalence of dependence, as judged by risk estimates, include being a male, having a low socioeconomic status, and being a single child-rearing parent. Factors associated with increased risk based on prevalence of dependence intensity, as judged by risk estimates, include being a child of an alcoholic and/or cocaine-using parent and having a history of alcohol or drug misuse by an older sibling.

Unverified Answer

Can cocaine use disorders be cured?

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Cocaine use disorder is a persistent, chronic condition with no current cure. However, research and clinical treatments have contributed to the creation of a viable program that decreases substance use and promotes remission and recovery.

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What are the signs of cocaine use disorders?

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Cocaine use disorder subjects show some specific symptoms of cocaine use such as cravings, paranoia, irritability, anxiety; and some subjects with symptoms of cocaine use disorders such as cravings, paranoia, irritability, anxiety and agitation. These symptoms can be observed at any stage of cocaine use which may be the cause of cocaine use disorder. Moreover, the symptoms of cocaine use disorder appear as different from those of cocaine dependence. It implies that cocaine use disorder and cocaine dependence have different etiology.

Unverified Answer

What is cocaine use disorders?

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Individuals with a cocaine use disorder have at their peak level less control over cocaine use, and as they progress through their cocaine use, the severity of all three problems increases. When treated with MMT, these patients are more likely to use a greater amount of less-controllable cocaine (as opposed to cocaine infused through a smoking pipe or a water pipe), have substantially fewer medical visits with their physician, and experience less illicit cocaine use, as compared with those patients without cocaine use disorders. More research should be done to further understand what treatments are most effective for treating cocaine use disorders.

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What are common treatments for cocaine use disorders?

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Treatment for cocaine-related disorders in North America is broadly diverse. Treatment in this context should include psychoeducation (as well as cognitive behavioral therapy or medication therapy) and contingency management therapy.

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How many people get cocaine use disorders a year in the United States?

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About 1 in 5 cocaine abusers (16.9%) have a dual diagnosis. Cocaine abusers in the U.S. are aged 14 to 33 years and mainly use cocaine once a week or more. Cocaine addiction is understudied.

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What are the latest developments in treatment for therapeutic use?

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The use of buprenorphine as a maintenance therapy for cocaine addiction is increasing. The use of naltrexone is also increasing. These interventions may be effective but do not appear to reduce cocaine use or reduce cocaine dependence.

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Is treatment safe for people?

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Results from a recent clinical trial are inconsistent with published data from clinical trials and with research showing that relapse rates are highly similar to those observed in the community. The findings suggest that there is insufficient evidence to support the hypothesis that methadone treatment is safer than other opioid-based treatments.

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Have there been any new discoveries for treating cocaine use disorders?

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A number of the proposed new treatments are currently undergoing clinical trials. A number of treatments are in this process of development and research. Research in some areas is ongoing. Many new treatments have been proposed but only a handful are effective and many more are not effective in the long run. There should be a research agenda in drug development that includes treatments effective at long-term, in the long run. This research deserves continued funding and attention and continued scrutiny of drug abuse interventions.\n[Example of treatments: nicotine replacement therapy, motivational interviewing and contingency management, cognitive behavioral therapy, behavioral support and relapse prevention, behavioral activation and stimulus control therapy, a new combination of cognitive processing therapy and motivational interviewing, and new, short-acting medication for relapse prevention.

Unverified Answer

What is treatment?

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Treatment includes psychotherapy (with or without CBT) and medications (e.g., CBT, anticonvulsives, anorectics, mood stabilisers, antidepressants, benzodiazepines, opiates, etc.). Some medications used in the short term can be converted to a low dose for use as a maintenance therapy, with the added rationale that they are less likely to cause relapse. This approach can reduce medication consumption. In the long-term the benefits of medication as compared to psychotherapy remain unclear.

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Has treatment proven to be more effective than a placebo?

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Evidence suggests that treatment-based recovery and treatment continuation are more effective in reducing or eliminating abuse-related problems than a placebo. However, there is substantial variation in treatment efficacy for individual treatments in various clinical trials.

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What is the latest research for cocaine use disorders?

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The most recent research on cocaine use disorders has narrowed down the number of drugs used by those with cocaine use disorders to just three (cocaine, methamphetamine, and marijuana). As those who engage in addiction therapies learn more about the different drugs used, medical professionals and clinicians can provide treatment options. The goal for treating cocaine use disorder patients is to encourage abstinence and help the individuals get stable jobs after their drug use has ended, so that they can remain healthy. For more information about how to find cocaine use disorder clinical trials, visit [Power(https://www.withpower.com/alzheimer%27s-disease-clinical-trials)]. (\n1.

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