Cocaine DependenceEarly Phase 1NCT01906346
Impact of a Non-Drug Choice on Cocaine Reinforcement
A Early Phase 1 study testing Cocaine in people with Cocaine Dependence, 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
- Cocaine Dependence
- What is being tested?
- Cocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2014to Jun 2015
- 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
- Cocaine dependence, 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 self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.
- Conditions
- Cocaine Dependence
- Being tested
- Cocaine, Placebo
- Medical subject headings
- Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocaineDrug
Three active doses of cocaine will be made available for self-administration during experimental sessions.
PlaceboDrug
Placebo cocaine will be made available for self-administration during experimental sessions.
| Study group | Role | What they receive |
|---|---|---|
| Low Value Alternative Reinforcer | Experimental | A low value reinforcer will be made available as an alternative to cocaine and placebo. Receives: Drug: Cocaine; Drug: Placebo |
| Medium Value Reinforcer | Experimental | A medium value reinforcer will be made available as an alternative to cocaine and placebo. Receives: Drug: Cocaine; Drug: Placebo |
| High Value Reinforcer | Experimental | A high value reinforcer will be made available as an alternative to cocaine and placebo. Receives: Drug: Cocaine; Drug: Placebo |
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 in which subjects made 9 choices between each available cocaine dose and one of three money alternatives.
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 posted24 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
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 Cocaine DependenceStudies 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
- 9 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
- Investigators
- Joshua A Lile, Ph.D, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906346
- Sponsor's protocol ID
- R01DA033364-01
- Status last verified
- Apr 2019
- First submitted
- 16 Jul 2013
- Last updated
- 17 May 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 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Non-Drug Choice on Cocaine Reinforcement
- ClinicalTrials.gov ID
- NCT01906346
- Acronym / sponsor ID
- R01DA033364-01
- Conditions
- Cocaine Dependence
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Joshua A. Lile, Ph.D.University, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Jul 2013 (estimated)
- Results
- Posted 17 May 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 self-administration procedures and a non-drug alternative reinforcer, which is hypothesized to reduce the reinforcing effects of cocaine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Value Alternative Reinforcer | Experimental | Drug: Cocaine, Drug: PlaceboA low value reinforcer will be made available as an alternative to cocaine and placebo. |
| Medium Value Reinforcer | Experimental | Drug: Cocaine, Drug: PlaceboA medium value reinforcer will be made available as an alternative to cocaine and placebo. |
| High Value Reinforcer | Experimental | Drug: Cocaine, Drug: PlaceboA high value reinforcer will be made available as an alternative to cocaine and placebo. |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Cocaine dependence, 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 |
|---|---|---|
| CocaineThree active doses of cocaine will be made available for self-administration during experimental sessions. | Drug | High Value Reinforcer, Low Value Alternative Reinforcer, Medium Value Reinforcer |
| PlaceboPlacebo cocaine will be made available for self-administration during experimental sessions. | Drug | High Value Reinforcer, Low Value Alternative Reinforcer, Medium Value Reinforcer |
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 in which subjects made 9 choices between each available cocaine dose and one of three money alternatives.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Joshua A Lile, Ph.D principal investigator
University of Kentucky
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 in people with Cocaine Dependence, 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 17 May 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. 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 17 May 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 17 May 2019.