Cocaine Use DisorderPhase 1NCT02239913
Topiramate-Phentermine Combinations for Cocaine Dependence
A Phase 1 study testing Cocaine, Phentermine and Topiramate in people with Cocaine Use Disorder, run by University of Kentucky at 1 site in United States.
Trial summary
This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cocaine Use Disorder
- What is being tested?
- Cocaine, Phentermine and Topiramate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Recent cocaine use by the intranasal or intravenous route
Who cannot join
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to cocaine, topiramate or phentermine
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky Medical Center
Lexington, Kentucky, 40536
About this study
This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.
- Conditions
- Cocaine Use Disorder
- Being tested
- Cocaine, Placebo, Phentermine, Topiramate
- Keywords
- Cocaine, Pharmacotherapy, Phentermine, Topiramate, Self-Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CocaineDrug
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
PlaceboDrug
The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
PhentermineDrug
Also called Adipex®
The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
TopiramateDrug
Also called Topamax®
The pharmacodynamic effects of chronic topiramate will be determined.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be maintained on oral placebo. Subjects will be maintained on placebo and phentermine during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Cocaine; Drug: Placebo; Drug: Phentermine |
| Topiramate Dose 1 | Experimental | Subjects will be maintained on the low topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the low dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Cocaine; Drug: Placebo; Drug: Phentermine; Drug: Topiramate |
| Topiramate Dose 2 | Experimental | Subjects will be maintained on the high topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the high dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. Receives: Drug: Cocaine; Drug: Placebo; Drug: Phentermine; Drug: Topiramate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reinforcing Effects
The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses.
Measured: Nine times over approximately five weeks inpatient admission.
Secondary outcomes (3)
Subjective effects
Subjects will complete subjective effects measures during nine sessions while they are admitted to our inpatient unit. These items will ask about drug effects and general mood.
Measured: Nine times over approximately five weeks inpatient admission.
Physiological Effects
Physiological measures will be completed daily while subjects are admitted to our inpatient unit. Physiological measures include temperature, heart rate and blood pressure.
Measured: Daily over approximately five week inpatient admissions
Side effects
Subjects will complete a side effects questionnaire daily while they reside on the inpatient unit. Side Effects questions will query subjects about common effects of centrally active medications.
Measured: Daily over approximately five weeks of inpatient admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cocaine Use DisorderStudies 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Craig Rush, University of Kentucky
- Investigators
- Craig R Rush, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02239913
- Sponsor's protocol ID
- BED IN 27
- Other IDs
- R01DA032254
- Status last verified
- Nov 2019
- First submitted
- 10 Sep 2014
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topiramate-Phentermine Combinations for Cocaine Dependence
- ClinicalTrials.gov ID
- NCT02239913
- Acronym / sponsor ID
- BED IN 27
- Conditions
- Cocaine Use Disorder
- Keywords
- Cocaine, Pharmacotherapy, Phentermine, Topiramate, Self-Administration
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 15 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the influence of topiramate (Topamax®) and phentermine (Adipex®), alone and in combination, on the reinforcing, subjective and physiological effects of cocaine.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Cocaine, Drug: Placebo, Drug: PhentermineSubjects will be maintained on oral placebo. Subjects will be maintained on placebo and phentermine during placebo maintenance. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
| Topiramate Dose 1 | Experimental | Drug: Cocaine, Drug: Placebo, Drug: Phentermine, Drug: TopiramateSubjects will be maintained on the low topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the low dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
| Topiramate Dose 2 | Experimental | Drug: Cocaine, Drug: Placebo, Drug: Phentermine, Drug: TopiramateSubjects will be maintained on the high topiramate dose. Subjects will be maintained on placebo and phentermine during maintenance on the high dose of topiramate. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Recent cocaine use by the intranasal or intravenous route
Key exclusion criteria (5 listed)
- Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
- Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
- History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
- Females not currently using effective birth control
- Contraindications to cocaine, topiramate or phentermine
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 |
|---|---|---|
| CocaineThe pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate. | Drug | Placebo, Topiramate Dose 1, Topiramate Dose 2 |
| PlaceboThe pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate. | Drug | Placebo, Topiramate Dose 1, Topiramate Dose 2 |
| PhentermineAlso: Adipex®The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate. | Drug | Placebo, Topiramate Dose 1, Topiramate Dose 2 |
| TopiramateAlso: Topamax®The pharmacodynamic effects of chronic topiramate will be determined. | Drug | Topiramate Dose 1, Topiramate Dose 2 |
Primary outcome
Reinforcing Effects
Time frame: Nine times over approximately five weeks inpatient admission.
The reinforcing effects of cocaine will be determined using a self-administration procedure in which subjects choose to take previously sampled doses.
3 secondary outcomes
Subjective effects
Time frame: Nine times over approximately five weeks inpatient admission.
Physiological Effects
Time frame: Daily over approximately five week inpatient admissions
Side effects
Time frame: Daily over approximately five weeks of inpatient admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
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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.
Craig R Rush, 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 Phase 1 study testing Cocaine, Phentermine and Topiramate in people with Cocaine Use Disorder, run by University of Kentucky 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 5 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 27 Nov 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reinforcing Effects (time frame: Nine times over approximately five weeks inpatient admission.). 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 27 Nov 2019.