Active Cocaine UsersEarly Phase 1NCT02383043
Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
A Early Phase 1 study testing Cocaine and Sustained Release d-Amphetamine in people with Active Cocaine Users, run by Joshua A. Lile, Ph.D. at 1 site in United States.
Trial summary
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. Read more about this study
- Who is it for?
- Ages 21 to 45 years
- Conditions the study is for
- Active Cocaine Users
- What is being tested?
- Cocaine and Sustained Release d-Amphetamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2015to 5 Apr 2018
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Recent cocaine use, otherwise healthy
Who cannot join
- Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory of Human Behavioral Pharmacology
Lexington, Kentucky, 40536-0086
About this study
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.
- Conditions
- Active Cocaine Users
- Being tested
- Cocaine, Sustained Release d-Amphetamine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocaineDrug
Sustained Release d-AmphetamineDrug
Also called Dexedrine Spansule SR
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Cocaine choice during d-amphetamine maintenance Receives: Drug: Cocaine; Drug: Sustained Release d-Amphetamine |
| Placebo Treatment | Placebo comparator | Cocaine choice during placebo maintenance Receives: Drug: Cocaine; Drug: Sustained Release d-Amphetamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance.
Measured: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study start1 Feb 2015
- Primary completion5 Apr 2018
- Study completion5 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Active Cocaine UsersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua A. Lile, Ph.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua A. Lile, Ph.D., University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383043
- Sponsor's protocol ID
- R01DA033364-02
- Status last verified
- Mar 2019
- First submitted
- 27 Feb 2015
- Last updated
- 11 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sustained Release d-Amphetamine on Choice Between Cocaine and a Non-Drug Reinforcer
- ClinicalTrials.gov ID
- NCT02383043
- Acronym / sponsor ID
- R01DA033364-02
- Conditions
- Active Cocaine Users
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Joshua A. Lile, Ph.D.University, hospital or other
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 5 Apr 2018 (actual)
- Study completion
- 5 Apr 2018 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 11 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cocaine-use disorders continue to be a significant public health concern, yet no effective medications have been identified. The goal of this study is to establish a research platform for the development of medications for treatment of cocaine abuse and dependence. This study will incorporate choice self-administration procedures between drug and a non-drug alternative reinforcer presented during maintenance on d-amphetamine, which has been previously shown to reduce cocaine use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Drug: Cocaine, Drug: Sustained Release d-AmphetamineCocaine choice during d-amphetamine maintenance |
| Placebo Treatment | Placebo comparator | Drug: Cocaine, Drug: Sustained Release d-AmphetamineCocaine choice during placebo maintenance |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recent cocaine use, otherwise healthy
Key exclusion criteria (1 listed)
- Laboratory results outside of clinically acceptable ranges, history of or current serious physical or psychiatric disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cocaine | Drug | Active Treatment, Placebo Treatment |
| Sustained Release d-AmphetamineAlso: Dexedrine Spansule SR | Drug | Active Treatment, Placebo Treatment |
Primary outcome
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative
Time frame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes
The reinforcing effects of cocaine were determined using a modified progressive ratio procedure (Lile et al., 2016) in which subjects made 9 choices between each available cocaine dose and money (US$6.00). Reinforcing effects are measured for each cocaine dose during both d-amphetamine and placebo maintenance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cocaine and Sustained Release d-Amphetamine in people with Active Cocaine Users, run by Joshua A. Lile, Ph.D. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Times Cocaine Was Selected in the Presence of a Monetary Reward Alternative (time frame: 9 choice trials per cocaine dose level with each trial separated by 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.