Cocaine DependencePhase 2NCT05562349
Clavulanic Acid for the Treatment of Cocaine Use Disorder
A Phase 2 study testing Clavulanic Acid Only Product in people with Cocaine Dependence, run by Temple University at 2 sites in United States.
Trial summary
A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cocaine Dependence
- What is being tested?
- Clavulanic Acid Only Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 May 2023to Jul 2024
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Be male or female adult volunteers ages 18-70 inclusive.
- Have a Diagnostic and Statistical Manual (DSM-V) diagnosis of cocaine use disorder, moderate to severe in early remission with a duration of regular (weekly or more) cocaine (either snorted, smoked or injected) for at least one year.
- Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.
Who cannot join
- Meets DSM-V criteria for dependence on any substance other than cocaine and mild to moderate alcohol or marijuana (except nicotine or caffeine), determined by the structured clinical interview for DSM-V.
- Allergy to clavulanic acid, penicillin, or any beta-lactam drug.
- Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-V diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
- Severe physical or medical illnesses such as AIDS or active hepatitis.
- If female, tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
MUSC
Charleston, South Carolina, 29403
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 2a Pilot Study to Assess the Efficacy and Safety of Clavulanic Acid vs. Placebo for the Treatment of Cocaine Use Disorder
A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)
Read the detailed description
This pilot study is indicated for treatment of moderate to severe cocaine use disorder. It is a randomized, placebo-controlled, parallel group, multi-center pilot study to compare the efficacy of 500-750mg/day clavulanic acid vs. placebo in addition to weekly medication management therapy. Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed 1-3 times weekly.
- Conditions
- Cocaine Dependence
- Being tested
- Clavulanic Acid Only Product, 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.
Clavulanic Acid Only ProductDrug
Also called Potassium clavulanate
Drug will be given in 250mg capsules
PlaceboDrug
Also called microcrystalline cellulose
Capsule with no active medication - identical to drug capsule
| Study group | Role | What they receive |
|---|---|---|
| Clavulanic Acid | Experimental | Participants may receive 500 mg of CLAV at baseline. Subjects who are using cocaine once per week or more and who can tolerate 500 mg/day for 4 weeks, will have a dose escalation to 750 mg/day. If tolerated, 750mg/day will be maintained for 8 weeks, otherwise the dose will decrease to 500mg/day. Receives: Drug: Clavulanic Acid Only Product |
| Placebo | Placebo comparator | Participants may receive placebo and serve as a control group. They will be blinded to their condition and will have a "dose" escalation at the same time as the experimental group, and be given additional placebo pills to match the number given to the experimental group. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in relapse to cocaine use in CLAV group vs PBO group
Cocaine-free weeks are measured by self-report using Timeline Follow Back (TLFB) and confirmed by urine drug screen.
Measured: Last 3 weeks of 12 week study
Secondary outcomes (5)
Changes in weekly abstinence in the CLAV group vs. PBO group
Abstinence from cocaine by week will be measured by self report and urine drug screen
Measured: Self reported cocaine use and Urine Drug Screen (UDS) will be administered 1-3 times per week and at follow-up
Changes in weekly cocaine use will be greater in the CLAV group vs. PBO group
Cocaine-free visits are measured by self-report using TLFB confirmed by urine drug screen
Measured: TLFB and UDS will be administered 1-3 times per week and at follow-up
Changes in subject health and function, quality-of-life, will be greater in the CLAV group vs. PBO group
Medical Outcomes Study Quality of Life Scale short form 36, will determine whether CLAV treatment is associated with improved QOL
Measured: Baseline, week 4, week 8, week 12
Clavulanic acid 500-750 mg/day for 12 weeks will be safe and reasonably well tolerated
Safety and tolerability as assessed by the rates of occurrence of adverse events (AEs) and the severity
Measured: 1-3 times per week and at follow-up
Cocaine craving will be decreased more by CLAV vs. PBO
Changes in craving will be greater in the CLAV group compared with PBO group, as measured by the cocaine craving questionnaire (CCQ), adjusted for baseline and sex
Measured: 1-3 times per week and at follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study start3 May 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel group study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Medical University of South Carolina, Research Foundation for Mental Hygiene, Inc.
- Responsible party
- Sponsor
- Investigators
- Mary Morrison, MD, MS, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05562349
- Sponsor's protocol ID
- 30076
- Status last verified
- Apr 2024
- First submitted
- 15 Sep 2022
- Last updated
- 2 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim J, John J, Langford D, Walker E, Ward S, Rawls SM. Clavulanic acid enhances glutamate transporter subtype I (GLT-1) expression and decreases reinforcing efficacy of cocaine in mice. Amino Acids. 2016 Mar;48(3):689-696. doi: 10.1007/s00726-015-2117-8. Epub 2015 Nov 5.
PubMed 26543027
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 2a Pilot Study to Assess the Efficacy and Safety of Clavulanic Acid vs. Placebo for the Treatment of Cocaine Use Disorder
- ClinicalTrials.gov ID
- NCT05562349
- Acronym / sponsor ID
- 30076
- Conditions
- Cocaine Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Medical University of South Carolina, Research Foundation for Mental Hygiene, Inc.
- Study start
- 3 May 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 Sep 2022 (actual)
- 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.
A dose escalation study to assess the efficacy and safety of Clavulanic Acid (CLAV) vs. placebo (PBO) for the treatment of cocaine use disorder (CUD)
Detailed description
This pilot study is indicated for treatment of moderate to severe cocaine use disorder. It is a randomized, placebo-controlled, parallel group, multi-center pilot study to compare the efficacy of 500-750mg/day clavulanic acid vs. placebo in addition to weekly medication management therapy. Subjective, cognitive, and adverse effect assessments, blood pressure and pulse will be performed 1-3 times weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel group study
| Arm | Type | Receives |
|---|---|---|
| Clavulanic Acid | Experimental | Drug: Clavulanic Acid Only ProductParticipants may receive 500 mg of CLAV at baseline. Subjects who are using cocaine once per week or more and who can tolerate 500 mg/day for 4 weeks, will have a dose escalation to 750 mg/day. If tolerated, 750mg/day will be maintained for 8 weeks, otherwise the dose will decrease to 500mg/day. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants may receive placebo and serve as a control group. They will be blinded to their condition and will have a "dose" escalation at the same time as the experimental group, and be given additional placebo pills to match the number given to the experimental group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be able to verbalize understanding of consent form, able to provide written informed consent, and verbalize willingness to complete study procedures
- Be male or female adult volunteers ages 18-70 inclusive.
- Have a Diagnostic and Statistical Manual (DSM-V) diagnosis of cocaine use disorder, moderate to severe in early remission with a duration of regular (weekly or more) cocaine (either snorted, smoked or injected) for at least one year.
- Have a history and brief physical examination that demonstrate no clinically significant contraindication for participating in the study, and/ or significant or unstable medical or psychiatric illness.
Key exclusion criteria (5 listed)
- Meets DSM-V criteria for dependence on any substance other than cocaine and mild to moderate alcohol or marijuana (except nicotine or caffeine), determined by the structured clinical interview for DSM-V.
- Allergy to clavulanic acid, penicillin, or any beta-lactam drug.
- Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder or organic mental disorder. Subject meets current DSM-V diagnosis of any other clinically significant psychiatric disorder that will interfere with study participation.
- Severe physical or medical illnesses such as AIDS or active hepatitis.
- If female, tests positive on a pregnancy test, is contemplating pregnancy in the next 6 months, is nursing, or is not using an effective contraceptive method (if relevant)
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 |
|---|---|---|
| Clavulanic Acid Only ProductAlso: Potassium clavulanateDrug will be given in 250mg capsules | Drug | Clavulanic Acid |
| PlaceboAlso: microcrystalline celluloseCapsule with no active medication - identical to drug capsule | Drug | Placebo |
Primary outcome
Changes in relapse to cocaine use in CLAV group vs PBO group
Time frame: Last 3 weeks of 12 week study
Cocaine-free weeks are measured by self-report using Timeline Follow Back (TLFB) and confirmed by urine drug screen.
5 secondary outcomes
Changes in weekly abstinence in the CLAV group vs. PBO group
Time frame: Self reported cocaine use and Urine Drug Screen (UDS) will be administered 1-3 times per week and at follow-up
Changes in weekly cocaine use will be greater in the CLAV group vs. PBO group
Time frame: TLFB and UDS will be administered 1-3 times per week and at follow-up
Changes in subject health and function, quality-of-life, will be greater in the CLAV group vs. PBO group
Time frame: Baseline, week 4, week 8, week 12
Clavulanic acid 500-750 mg/day for 12 weeks will be safe and reasonably well tolerated
Time frame: 1-3 times per week and at follow-up
Cocaine craving will be decreased more by CLAV vs. PBO
Time frame: 1-3 times per week and at follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2024.
- Results publication: PubMed 26543027Kim J, John J, Langford D, Walker E, Ward S, Rawls SM. Clavulanic acid enhances glutamate transporter subtype I (GLT-1) expression and decreases reinforcing efficacy of cocaine in mice. Amino Acids. 2016 Mar;48(3):689-696. doi: 10.1007/s00726-015-2117-8. Epub 2015 Nov 5.
- Individual participant dataSharing planned: No
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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.
Mary Morrison, MD, MS principal investigator
Temple University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clavulanic Acid Only Product in people with Cocaine Dependence, run by Temple University at 2 sites 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 4 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: under way, not looking for participants, as of the sponsor's last update on 2 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Changes in relapse to cocaine use in CLAV group vs PBO group (time frame: Last 3 weeks of 12 week study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05562349, which also lists 1 linked publication.
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 2 May 2024.