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Study on Sustained-Release Dexamphetamine and Piracetam for Patients with Moderate to Severe Cocaine Use Disorder and Opioid Dependence

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a new treatment for individuals with cocaine use disorder who also have an opioid use disorder. The treatment being tested is a medication called Dexamphetamine sulfate/piracetam, which is provided in a form that releases the medication slowly over time. The purpose of the study is to evaluate how effective this treatment is in helping patients reduce their cocaine use and improve their overall health while they are also receiving routine treatment for their opioid dependence with oral methadone.

Participants in the study will receive either the Dexamphetamine sulfate/piracetam tablets or a placebo for a period of 24 weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. The study will monitor the number of days participants abstain from cocaine use and assess their overall health status, including physical, mental, and social well-being.

The trial will also track the safety of the treatment by checking vital signs such as heart rate and blood pressure, as well as conducting other health assessments. The goal is to determine if the treatment can help reduce cocaine use and improve health outcomes for those with both cocaine and opioid use disorders. Participants will be required to visit the treatment center twice a week and cooperate with study assessments and procedures throughout the trial period.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, participation in opioid treatment with oral methadone is required.
Written informed consent must be provided.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility, including a review of cocaine use disorder and current health status.
Step 3
Medication administration
The study involves taking sustained-release dexamphetamine tablets, with a dosage individually adjusted up to a maximum of 90 mg per day, as tolerated.
A placebo may be administered instead, containing a small dose of piracetam as a marker for adherence.
Step 4
Treatment duration
The treatment phase lasts for 24 weeks.
Regular visits to the treatment center are required twice a week.
Step 5
Monitoring and assessments
Health status, including physical and mental health, will be monitored throughout the study.
Vital signs, such as heart rate and blood pressure, will be checked regularly.
Safety assessments will include ECGs and laboratory tests.
Step 6
Final assessment
In the final four weeks of treatment, the number of days of cocaine abstinence will be evaluated.
Overall health status will be assessed to determine any improvements.
Step 7
Discontinuation phase
After the treatment phase, a discontinuation phase will occur, lasting an additional four weeks.
Cocaine abstinence and health status will be monitored during this phase.

Who can join the trial?

9 criteria

Currently taking part in **opioid agonist treatment** with oral **methadone**. This means you are receiving a medication called methadone to help with opioid dependence.
Have a **moderate or severe cocaine use disorder** according to **DSM-5**. This means your cocaine use is at a level that affects your daily life, as defined by a specific guideline called DSM-5.
Have used cocaine regularly in the past month.
Primarily use cocaine by **snorting**, **inhaling**, or **injecting**. These are different ways of taking cocaine.
Want to reduce or stop using cocaine.
Can and are willing to visit the treatment center two days a week.
Can and are willing to participate in the necessary study assessments and procedures.
Have given written informed consent, meaning you have agreed in writing to participate in the study after understanding what it involves.
Both males and females can participate.

Who cannot join the trial?

4 criteria

Patients who do not have a diagnosis of cocaine use disorder cannot participate. This means the study is only for those who have issues with cocaine use.
Patients who are not receiving oral methadone for opioid dependence cannot participate. Oral methadone is a medication used to help people with opioid addiction.
Patients who are not in the age range specified by the study cannot participate. The study is for adults, so children and teenagers are excluded.
Patients who are part of a vulnerable population, such as those unable to give informed consent, are not included in the study.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Geneeskundige en Gezondheidsdienst Amsterdam
Verified
Amsterdam, The Netherlands
Parnassia Groep B.V.
Verified
Hague, The Netherlands

Trial locations

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Investigated drugs

SR-dexamphetamine
is a medication being studied for its potential to help patients with moderate to severe cocaine use disorder. It is a sustained-release form of dexamphetamine, which means it is designed to release the medication slowly over time. The goal is to see if it can reduce cocaine use and improve overall health in patients who are also receiving treatment for opioid dependence.
Methadone
is a medication used in this study as part of the routine treatment for opioid dependence. It helps reduce withdrawal symptoms and cravings in people who are addicted to opioids, allowing them to focus on recovery and reducing the use of other substances like cocaine.

What is already known about the treatment

Dexamphetamine – This medication is administered orally in a sustained-release form, allowing for gradual absorption into the bloodstream. It is currently being studied in clinical trials for its potential use in treating cocaine use disorder, particularly in individuals who also have opioid use disorder. The main therapeutic indication is to reduce cocaine use and improve overall health in these patients. At the molecular level, dexamphetamine works by increasing the levels of certain neurotransmitters in the brain, such as dopamine and norepinephrine, which can help improve mood and reduce cravings. It is classified as a central nervous system stimulant.

Investigated diseases

Cocaine Use Disorder – Cocaine use disorder is a condition characterized by the compulsive use of cocaine, leading to significant impairment or distress. Individuals with this disorder often experience strong cravings for cocaine and may find it difficult to control their use despite negative consequences. Over time, the disorder can lead to increased tolerance, requiring more of the drug to achieve the same effects. This can result in a cycle of escalating use and withdrawal symptoms when not using the drug. The disorder can affect various aspects of life, including physical health, mental health, and social functioning. It is often associated with other substance use disorders, such as opioid dependence.