Study on Dexamfetamine for Adults with Amphetamine and Opioid Dependence Undergoing Opioid Treatment

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What is this study about?

This clinical trial is focused on studying the effects of a medication called dexamfetamine on individuals who have dependencies on both amphetamines and opioids. The study aims to understand how substituting dexamfetamine for illicit amphetamines affects the use of these substances in adults who are also receiving treatment for opioid dependence. Participants in the study will be given either dexamfetamine or a placebo, which looks like the active treatment but does not contain the active substance.

The purpose of the study is to assess the impact of taking dexamfetamine daily for 12 weeks compared to a placebo on the use of illicit amphetamines. The study will monitor the total amount of amphetamines used by participants who are undergoing treatment for opioid dependence. Participants will be randomly assigned to receive either the active medication or the placebo, and neither the participants nor the researchers will know which treatment is being given to ensure unbiased results.

Throughout the study, various aspects of the participants’ health and behavior will be observed, including psychological well-being, quality of life, and adherence to their opioid treatment. The study will also track any changes in the use of other substances, the occurrence of infections, and overall life satisfaction. The trial is expected to continue until the end of 2027, with recruitment starting in early 2024.

1 joining the study

Upon joining the study, eligibility is confirmed through a medical evaluation. This includes a review of medical history, a physical examination, laboratory tests, and heart monitoring.

Participants must be between 18 and 65 years old, have a history of amphetamine dependence for at least three years, and be receiving stable opioid treatment.

2 initial assessment

An initial assessment is conducted to establish baseline data. This includes psychological evaluations and self-reported data on amphetamine use.

Participants are informed about the study procedures and requirements, and consent is obtained.

3 medication administration

Participants are randomly assigned to receive either dexamfetamine or a placebo. The medication is administered orally in tablet form.

The dosage and frequency are determined by the study protocol, and the treatment lasts for 12 weeks.

4 ongoing monitoring

Throughout the 12-week period, participants undergo regular monitoring. This includes urine tests to detect illicit amphetamine use and assessments of psychological well-being.

Participants are also asked to report any side effects or changes in their condition.

5 final assessment

At the end of the 12 weeks, a final assessment is conducted. This includes a comprehensive evaluation of amphetamine use, psychological health, and overall treatment satisfaction.

Data collected during the study is analyzed to determine the impact of the treatment.

Who Can Join the Study?

Must be between 18 and 65 years old at the time of signing the consent form.
Must be in good health as determined by a medical check-up, which includes reviewing medical history, a physical exam, lab tests, and heart monitoring.
Must have been dependent on amphetamines for at least 3 years, using them at least 4 days a week in the last 28 days, and also have an opioid dependence. Must be receiving a stable dose of medication for opioid dependence in the last 28 days.
If female and able to have children, must use birth control as per local rules for clinical study participants. A pregnancy test may be required to confirm non-pregnancy.
Must be able to provide signed informed consent, agreeing to follow the study’s rules and restrictions.
Eligibility will be confirmed by a medical doctor through a clinical assessment.

Who Cannot Join the Study?

Having a dependency on both amphetamines and opioids. This means if you are addicted to both of these substances, you cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Helse Stavanger HF	Stavanger	Norway
Finnmarkssykehuset HF	Hammerfest	Norway
Sykehuset I Vestfold HF	Tonsberg	Norway
Hhyuj Bpmcaq Hv	Bergen	Norway
Sgophmpjy Travjgvd Hj	Skien	Norway
Aevxrhiw Uyrlvlsvwq Hdvmndda	Lorenskog	Norway

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.02.2024

Trial locations

Investigated drugs:

Dexamfetamine Sulfate

Dextroamphetamine is a medication used in this study to help reduce the use of illicit amphetamines in adults who are dependent on both amphetamines and opioids. Participants in the trial receive this medication daily for 12 weeks. The goal is to see if taking dextroamphetamine can decrease their use of illegal amphetamines while they are also receiving treatment for opioid dependence.

Investigated diseases:

Drug use disorder

Amphetamine Dependence – This condition involves a strong need to use amphetamines, which are stimulant drugs that affect the central nervous system. Individuals with this dependence may experience increased energy and alertness, but over time, they may require higher doses to achieve the same effects. The progression of this condition can lead to significant changes in behavior, including compulsive drug-seeking activities. Long-term use can result in physical and psychological issues, such as anxiety, insomnia, and mood swings. Dependence can also lead to neglect of personal and professional responsibilities. Withdrawal symptoms may occur if the drug use is reduced or stopped.

Opioid Dependence – This condition is characterized by a compulsive need to use opioids, which are substances that act on opioid receptors in the brain to produce pain relief and euphoria. Over time, individuals may develop tolerance, requiring larger amounts to achieve the desired effects. The progression of opioid dependence can lead to significant lifestyle disruptions, including neglect of daily responsibilities and relationships. Physical dependence can result in withdrawal symptoms when the drug is not taken. Long-term use can lead to health issues such as constipation, drowsiness, and respiratory problems. Psychological effects may include depression and anxiety.

Trial ID:

2023-508291-11-00

Trial Phase:

Therapeutic exploratory (Phase II)

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