15 Participants Needed

d-Amphetamine for Cocaine Use Disorder

Age: 18 - 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: Joshua A. Lile, Ph.D.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Do I need to stop my current medications to join the trial?

The protocol does not specify if you need to stop your current medications.

What data supports the idea that d-Amphetamine for Cocaine Use Disorder is an effective drug?

The available research shows that sustained-release dexamphetamine, a form of d-Amphetamine, has shown positive effects in treating patients with cocaine use disorder. One study demonstrated that it helped reduce cocaine use in patients. Another study found that participants who took dextroamphetamine had better retention in the program and fewer positive drug tests compared to those who took a placebo. These findings suggest that d-Amphetamine can be an effective option for treating cocaine use disorder.12345

What safety data exists for d-Amphetamine in treating cocaine use disorder?

Safety data for d-Amphetamine, particularly in the form of sustained-release dexamphetamine, has been evaluated in various studies. One study focused on its use for cocaine-dependent patients with comorbid opioid dependence, indicating positive effects beyond just reducing cocaine use. Another study investigated its safety and efficacy for methamphetamine dependence, suggesting its potential safety in similar stimulant use disorders. Additionally, safety evaluations have been conducted in the context of ADHD treatment with mixed amphetamine salts, which are related formulations, providing further insights into the safety profile of amphetamines.12678

Is the drug sustained-release d-amphetamine a promising treatment for cocaine use disorder?

Yes, sustained-release d-amphetamine is a promising treatment for cocaine use disorder. Research shows it can help reduce cocaine use and improve the health of patients with cocaine dependence.29101112

What is the purpose of this trial?

The objective of this protocol is to use a drug-vs-money choice task, reinforcement learning modeling and fMRI to determine the neurobehavioral and neurobiological decision-making "profile" associated with the decision to take cocaine and the reduced cocaine choice that occurs during a behavioral intervention (alternative money reinforcer) that models contingency management.

Research Team

JL

Joshua Lile, PhD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for individuals who have recently used cocaine but are generally healthy. They should not have any serious physical or psychiatric diseases, and their lab results must be within normal ranges to participate.

Inclusion Criteria

Recent cocaine use
You have recently used cocaine.
You are generally in good health.

Exclusion Criteria

I have a serious physical or mental health condition.
Laboratory results outside of clinically acceptable ranges

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a drug-vs-money choice task using reinforcement learning modeling and fMRI to assess decision-making profiles. Each session involves 200 trials with varying monetary reinforcers.

40 minutes per session

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Money
  • Sustained Release d-amphetamine
Trial Overview The study is testing whether sustained release d-amphetamine, a medication, can influence the choice between taking cocaine or receiving money. Participants' decisions will be studied using tasks, computer modeling, and brain imaging (fMRI).
Participant Groups
3Treatment groups
Experimental Treatment
Group I: $4.00 alternative reinforcer valueExperimental Treatment2 Interventions
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Group II: $1.00 alternative reinforcer valueExperimental Treatment2 Interventions
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.
Group III: $0.25 alternative reinforcer valueExperimental Treatment2 Interventions
Subjects complete 200 trials on a probabilistic concurrent choice procedure in which 3 mg/70 kg intravenous cocaine and an alternative monetary reinforcer are available during each trial. Each money value is tested in a separate session.

Sustained Release d-amphetamine is already approved in United States, United Kingdom for the following indications:

🇺🇸
Approved in United States as Dexedrine for:
  • Attention Deficit Disorder with Hyperactivity
  • Narcolepsy
🇬🇧
Approved in United Kingdom as Dexamfetamine sulfate for:
  • Attention Deficit Disorder with Hyperactivity
  • Narcolepsy

Find a Clinic Near You

Who Is Running the Clinical Trial?

Joshua A. Lile, Ph.D.

Lead Sponsor

Trials
6
Recruited
120+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials
2,658
Recruited
3,409,000+

Findings from Research

In a randomized trial with 49 participants, those receiving sustained-release dexamphetamine showed significantly better treatment retention (86.3 days) compared to the placebo group (48.6 days), indicating its potential effectiveness in supporting recovery from methamphetamine dependence.
Dexamphetamine treatment was associated with a significant reduction in methamphetamine dependence and withdrawal symptoms, and it was found to be safe, with no serious adverse events reported during the study.
Randomized controlled trial of dexamphetamine maintenance for the treatment of methamphetamine dependence.Longo, M., Wickes, W., Smout, M., et al.[2018]
In a study of 73 cocaine-dependent patients undergoing heroin-assisted treatment, SR-dexamphetamine significantly increased the number of cocaine abstinent days compared to placebo, indicating its efficacy in reducing cocaine use.
SR-dexamphetamine treatment also showed potential to improve overall health outcomes, particularly in patients who started with poor health, suggesting that it may have broader benefits beyond just reducing cocaine use.
Clinical effects beyond cocaine use of sustained-release dexamphetamine for the treatment of cocaine dependent patients with comorbid opioid dependence: secondary analysis of a double-blind, placebo-controlled randomized trial.Blanken, P., Nuijten, M., van den Brink, W., et al.[2021]
In a study involving 41 long-term amphetamine-dependent individuals, both those receiving dexamphetamine and those receiving only counseling showed reduced use of street amphetamines, indicating that both interventions were effective.
The group receiving dexamphetamine was more likely to attend counseling sessions, suggesting that this treatment may enhance engagement in therapy and support further research into its efficacy in a larger trial.
Pilot randomized controlled study of dexamphetamine substitution for amphetamine dependence.Shearer, J., Wodak, A., Mattick, RP., et al.[2019]

References

Randomized controlled trial of dexamphetamine maintenance for the treatment of methamphetamine dependence. [2018]
Clinical effects beyond cocaine use of sustained-release dexamphetamine for the treatment of cocaine dependent patients with comorbid opioid dependence: secondary analysis of a double-blind, placebo-controlled randomized trial. [2021]
Pilot randomized controlled study of dexamphetamine substitution for amphetamine dependence. [2019]
Pilot randomized double blind placebo-controlled study of dexamphetamine for cocaine dependence. [2019]
Dextroamphetamine for cocaine-dependence treatment: a double-blind randomized clinical trial. [2019]
An interim analysis of the Quality of Life, Effectiveness, Safety, and Tolerability (QU.E.S.T.) evaluation of mixed amphetamine salts extended release in adults with ADHD. [2019]
Dose effects and comparative effectiveness of extended release dexmethylphenidate and mixed amphetamine salts. [2021]
Effects of SHP465 mixed amphetamine salts in adults with ADHD in a simulated adult workplace environment. [2022]
How treatment improvement in ADHD and cocaine dependence are related to one another: A secondary analysis. [2022]
Dexmethylphenidate extended release: a review of its use in the treatment of attention-deficit hyperactivity disorder. [2021]
Dexmethylphenidate extended-release capsules for the treatment of attention deficit hyperactivity disorder. [2019]
Dexmethylphenidate extended-release capsules for attention deficit hyperactivity disorder. [2015]
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