Cocaine DependencePhase 1NCT02563769

Clavulanic Acid (CLAV) and Cocaine Interaction Safety Study

A Phase 1 study testing Clavulanic acid and Intravenous cocaine in people with Cocaine Dependence and Cocaine Addiction, run by Temple University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cocaine Dependence, Cocaine Addiction, Cocaine Abuse
What is being tested?: Clavulanic acid and Intravenous cocaine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 24 Oct 2016to 25 May 2018
Phase: 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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meet Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for cocaine use disorder, moderate to severe.
Be a non-treatment seeking cocaine user.
If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.

Who cannot join

Be seeking treatment for substance abuse.
(For full inclusion/exclusion criteria or for more information, please contact the site directly.)

Trial locations and contacts

1 site in 1 country.

United States1 site

Temple University Hospital - Episcopal Campus
Philadelphia, Pennsylvania, 19125

Other trials in United States

About this study

Official title: Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Clavulanic Acid

The main purpose of this study is to determine if it is safe to use the study drug, clavulanic acid, in combination with cocaine. In this study, subjects will receive intravenous (i.v.) cocaine and the study drug, clavulanic acid. The safety of clavulanic acid is being studied so future studies can be done to find out if this drug is helpful in treating cocaine dependence. Currently, there is no available medication treatment for cocaine dependence.

Read the detailed description

This is a prospective, placebo controlled inpatient crossover safety study of 3 doses (250 mg/day, 500 mg/day, 750 mg/day) of CLAV with an intravenous infusion of cocaine 40 mg. Subjects will be non-treatment seeking experienced cocaine dependent adults, ages 18-65 (N=12 completers, 21 estimated to enroll). Subjects will undergo a washout of the study drug for 5 half-lives between study drug administration sessions.

The primary objective will be to determine whether there are clinically significant adverse interactions between CLAV (250 mg/day; 500 mg/day; 750 mg/day) and intravenously administered cocaine in healthy, non-treatment seeking adults with cocaine use disorder.

Conditions: Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Cocaine-Related Disorders
Being tested: Clavulanic acid, Intravenous cocaine, Placebo
Keywords: Cocaine, Clavulanic Acid
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 acidDrug
Also called CLAV
Clavulanic acid will be administered orally in 250mg capsules
Intravenous cocaineDrug
Also called Coc
20/40mg Cocaine will be administered by IV
PlaceboDrug
Also called PBO
Placebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose

Study groups in NCT02563769
Study group	Role	What they receive
Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO)	Experimental	Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Clavulanic Acid 500 mg; Day #4: Placebo Receives: Drug: Clavulanic acid; Drug: Intravenous cocaine; Drug: Placebo
CLAV 250mg; PBO; then CLAV 500mg	Experimental	Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Placebo; Day #4: Clavulanic Acid 500 mg Receives: Drug: Clavulanic acid; Drug: Intravenous cocaine; Drug: Placebo
PBO; CLAV 250mg; then CLAV 500mg	Experimental	Clavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Placebo; Day #3: Clavulanic Acid 250 mg (low dose); Day #4: Clavulanic Acid 500 mg Receives: Drug: Clavulanic acid; Drug: Intravenous cocaine; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Severe Adverse Events (AEs)
Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment
See Adverse Event section for reporting of mild-moderate AEs.
Measured: 6 Days (Study Days 1, 2, 3, 4, 5, 10)
Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing
IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min preinfusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean heart rate (HR) at 2 minutes post IV cocaine infusion and the maximum (max) change in heart rate from baseline pre-infusion are reported (peak heart rate post-infusion minus baseline heart rate pre-infusion) are reported.
Measured: 4 Days (Study Days 2, 3, 4, 5)
Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing
IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min pre-infusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 2 minutes post IV cocaine infusion are reported. Also, the maximum (max) change in SBP snd DBP from baseline pre-infusion are reported (peak SBP or DBP post-infusion minus baseline SBP or DBP pre-infusion) are reported.
Measured: 4 Days (Study Days 2, 3, 4, 5)
Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing
ECG was done 15 min after IV cocaine infusion (following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg). The interval between the Q wave and the T wave, corrected (QTc) is reported.
Measured: 4 Days (Study Days 2, 3, 4, 5)

Secondary outcomes (4)

Pharmacokinetic (PK) Parameter of Cocaine-concentration
Cocaine concentrations are reported at 10 min and 30 minutes after cocaine infusion (70 and 90 minutes after administration of placebo (PBO), CLAV 250mg or CLAV 500mg).
Measured: 3 Days (Study Days 2, 3, 4)
Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses
CLAV concentrations were measured 40 min and 70 min after ingestion of CLAV 250 mg or 500 mg. (The 70 min time point is 10 min after the IV cocaine infusion).The 250mg dose and the 500mg dose were given on different days per the randomization protocol: the 250mg dose was given on either day 2 or 3 and the 500mg dose was given on either day 3 or 4.
The lowest level of detection of CLAV is 40ng/ml. A non-detectable level is reported as 0.
Measured: 3 Days (Study Days 2, 3, 4)
Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses
The CLAV concentration after ingestion of 250mg CLAV minus the CLAV PK level after the 500 mg dose is reported at 40min and 70 min after ingestion
Measured: 3 days (Day 2, 3, 4)
Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
Pupil Diameter (mm) was measured 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion. Cocaine infusion was done 1 hour following ingestion of placebo (day 2), CLAV 250 mg (day3), or CLAV 500 mg (day 4). Results are reported as median pupil diameter (mm) with interquartile range at different time points relative to the cocaine infusion as noted.
Measured: 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Oct 201625 May 2018

First posted30 Sep 2015 (estimated)
Study start24 Oct 2016
Primary completion25 May 2018
Study completion25 May 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.
Publications (4)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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02563769
Sponsor's protocol ID: 23222
Other IDs: 1U54DA039002-01
Status last verified: Oct 2023
First submitted: 6 Aug 2015
Last updated: 3 Nov 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Uys JD, LaLumiere RT. Glutamate: the new frontier in pharmacotherapy for cocaine addiction. CNS Neurol Disord Drug Targets. 2008 Nov;7(5):482-91. doi: 10.2174/187152708786927868.
PubMed 19128205
Rasmussen BA, Baron DA, Kim JK, Unterwald EM, Rawls SM. beta-Lactam antibiotic produces a sustained reduction in extracellular glutamate in the nucleus accumbens of rats. Amino Acids. 2011 Feb;40(2):761-4. doi: 10.1007/s00726-010-0589-0. Epub 2010 Apr 13.
PubMed 20383795
Ward SJ, Rasmussen BA, Corley G, Henry C, Kim JK, Walker EA, Rawls SM. Beta-lactam antibiotic decreases acquisition of and motivation to respond for cocaine, but not sweet food, in C57Bl/6 mice. Behav Pharmacol. 2011 Aug;22(4):370-3. doi: 10.1097/FBP.0b013e3283473c10.
PubMed 21543969
Kovalevich J, Corley G, Yen W, Rawls SM, Langford D. Cocaine-induced loss of white matter proteins in the adult mouse nucleus accumbens is attenuated by administration of a beta-lactam antibiotic during cocaine withdrawal. Am J Pathol. 2012 Dec;181(6):1921-7. doi: 10.1016/j.ajpath.2012.08.013. Epub 2012 Sep 29.
PubMed 23031254

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cocaine Dependence trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Clavulanic Acid
ClinicalTrials.gov ID: NCT02563769
Acronym / sponsor ID: 23222
Conditions: Cocaine Dependence, Cocaine Addiction, Cocaine Abuse, Cocaine-Related Disorders
Keywords: Cocaine, Clavulanic Acid
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Temple UniversityUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA), University of Pennsylvania
Study start: 24 Oct 2016 (actual)
Primary completion: 25 May 2018 (actual)
Study completion: 25 May 2018 (actual)
First posted: 30 Sep 2015 (estimated)
Results: Posted 3 Nov 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO)	Experimental	Drug: Clavulanic acid, Drug: Intravenous cocaine, Drug: PlaceboClavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Clavulanic Acid 500 mg; Day #4: Placebo
CLAV 250mg; PBO; then CLAV 500mg	Experimental	Drug: Clavulanic acid, Drug: Intravenous cocaine, Drug: PlaceboClavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Clavulanic Acid 250 mg (low dose); Day #3: Placebo; Day #4: Clavulanic Acid 500 mg
PBO; CLAV 250mg; then CLAV 500mg	Experimental	Drug: Clavulanic acid, Drug: Intravenous cocaine, Drug: PlaceboClavulanic acid OR Placebo to be given in combination with intravenous cocaine; Day #2: Placebo; Day #3: Clavulanic Acid 250 mg (low dose); Day #4: Clavulanic Acid 500 mg

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Meet Diagnostic and Statistical Manual of Mental Disorders Fifth Edition criteria for cocaine use disorder, moderate to severe.
Be a non-treatment seeking cocaine user.
If female and of childbearing potential, must have a negative pregnancy test within 48 hours of beginning the study and be willing to use acceptable contraception or be abstinent for 14 days prior to study, through the entire study and 30 days after study participation.

Key exclusion criteria (2 listed)

Be seeking treatment for substance abuse.
(For full inclusion/exclusion criteria or for more information, please contact the site directly.)

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 acidAlso: CLAVClavulanic acid will be administered orally in 250mg capsules	Drug	CLAV 250mg; PBO; then CLAV 500mg, Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO), PBO; CLAV 250mg; then CLAV 500mg
Intravenous cocaineAlso: Coc20/40mg Cocaine will be administered by IV	Drug	CLAV 250mg; PBO; then CLAV 500mg, Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO), PBO; CLAV 250mg; then CLAV 500mg
PlaceboAlso: PBOPlacebo will be administered orally in capsules identical to CLAV and be filled with crystalline microcellulose	Drug	CLAV 250mg; PBO; then CLAV 500mg, Clavulanic Acid (CLAV) 250mg; CLAV 500mg then Placebo (PBO), PBO; CLAV 250mg; then CLAV 500mg

Primary outcome

Number of Participants With Severe Adverse Events (AEs)
Time frame: 6 Days (Study Days 1, 2, 3, 4, 5, 10)
Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment See Adverse Event section for reporting of mild-moderate AEs.
Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing
Time frame: 4 Days (Study Days 2, 3, 4, 5)
IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min preinfusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean heart rate (HR) at 2 minutes post IV cocaine infusion and the maximum (max) change in heart rate from baseline pre-infusion are reported (peak heart rate post-infusion minus baseline heart rate pre-infusion) are reported.
Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing
Time frame: 4 Days (Study Days 2, 3, 4, 5)
IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min pre-infusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 2 minutes post IV cocaine infusion are reported. Also, the maximum (max) change in SBP snd DBP from baseline pre-infusion are reported (peak SBP or DBP post-infusion minus baseline SBP or DBP pre-infusion) are reported.
Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing
Time frame: 4 Days (Study Days 2, 3, 4, 5)
ECG was done 15 min after IV cocaine infusion (following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg). The interval between the Q wave and the T wave, corrected (QTc) is reported.

4 secondary outcomes

Pharmacokinetic (PK) Parameter of Cocaine-concentration
Time frame: 3 Days (Study Days 2, 3, 4)
Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses
Time frame: 3 Days (Study Days 2, 3, 4)
Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses
Time frame: 3 days (Day 2, 3, 4)
Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
Time frame: 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4

Results and safety

Results posted to the registry on 3 Nov 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo; Clav 250mg, Then Clav 500mg	3	3
Clav 250mg; Placebo; Then Clav 500mg	3	3
Clav 250mg; Clav 500mg; Then Placebo	4	4

Primary outcome: Number of Participants With Severe Adverse Events (AEs)

Time frame: 6 Days (Study Days 1, 2, 3, 4, 5, 10). Count of participants. Unit: Participants

Measure	Day 1 - IV Cocaine Only n = 10	Placebo (PBO) n = 10	CLAV 250mg n = 10	CLAV 500mg n = 10	Day 5--CLAV 750mg n = 5	Day 10--Follow up n = 10
Value	0	0	0	0	0	0

Population analysed: Participants were adults (18-65) with current cocaine use disorder who were recruited from the greater Philadelphia area.

Primary outcome: Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing

Time frame: 4 Days (Study Days 2, 3, 4, 5). Mean (Standard Deviation). Unit: beats per minute

Measure	Placebo (PBO) n = 10	CLAV 250mg n = 10	CLAV 500mg n = 10	Day 5--CLAV 750mg n = 4
HR at 2 min	82.2 (14.7)	78.0 (5.7)	86.8 (13.0)	91.0 (14.7)
Max change in HR from baseline	26.3 (22.6)	29.8 (19.2)	32.0 (26.3)	27.7 (24.7)

Population analysed: 10 participants were randomized to receive PBO or CLAV 250mg or 500mg on days 2,3 and 4 followed one hour later by IV infusion of cocaine. Part way through the study, a 5th day was added giving CLAV 750mg 1hr before the cocaine infusion (Protocol V2.3). Five participants were eligible for Day 5 but one had technical issues with the cocaine infusion and did not receive the full cocaine dose, so that subject is excluded from the report of day 5 effects.

Primary outcome: Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing

Time frame: 4 Days (Study Days 2, 3, 4, 5). Mean (Standard Deviation). Unit: mm Hg

Measure	Placebo (PBO) n = 10	CLAV 250mg n = 10	CLAV 500mg n = 10	Day 5--CLAV 750mg n = 4
SBP at 2 min	138.8 (14.8)	135.0 (15.4)	140.0 (13.6)	137.8 (15.5)
Max change in SBP	21.6 (13.0)	23.5 (11.3)	18.4 (8.9)	20.9 (16.4)
DBP at 2 mim	88.5 (4.6)	88.8 (11.2)	89.5 (7.2)	87.8 (10.0)
Max change in DBP	12.1 (2.7)	13.3 (4.1)	12.6 (5.1)	12.7 (3.9)

Primary outcome: Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing

Time frame: 4 Days (Study Days 2, 3, 4, 5). Mean (Standard Deviation). Unit: ms

Measure	Placebo (PBO) n = 10	CLAV 250mg n = 10	CLAV 500mg n = 10	Day 5--CLAV 750mg n = 4
Value	431.8 (16.6)	432.3 (19.9)	430.5 (16.3)	431.3 (14.8)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Event Data was systematically collected daily during the 5 or 6 day inpatient period and up to their follow up visit at day 10. Any subjects who continued to experience adverse events after the follow up visit were followed until all adverse events resolved.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Day 1-IV Cocaine Infusion Only	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Placebo + IV Cocaine	0 of 10 (0%)	4 of 10 (40%)	0 of 10
CLAV 250mg + IV Cocaine	0 of 10 (0%)	3 of 10 (30%)	0 of 10
CLAV 500mg + IV Cocaine	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Day 5--CLAV 750mg + IV Cocaine	0 of 5 (0%)	2 of 5 (40%)	0 of 5
Discharge Day	0 of 10 (0%)	5 of 10 (50%)	0 of 10
Day 10-Follow-up	0 of 10 (0%)	4 of 10 (40%)	0 of 10

Limitations and caveats (from the sponsor): The sample size was relatively small (n=10) and the current study was not powered to adequately explore efficacy.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19128205Uys JD, LaLumiere RT. Glutamate: the new frontier in pharmacotherapy for cocaine addiction. CNS Neurol Disord Drug Targets. 2008 Nov;7(5):482-91. doi: 10.2174/187152708786927868.
Background: PubMed 20383795Rasmussen BA, Baron DA, Kim JK, Unterwald EM, Rawls SM. beta-Lactam antibiotic produces a sustained reduction in extracellular glutamate in the nucleus accumbens of rats. Amino Acids. 2011 Feb;40(2):761-4. doi: 10.1007/s00726-010-0589-0. Epub 2010 Apr 13.
Background: PubMed 21543969Ward SJ, Rasmussen BA, Corley G, Henry C, Kim JK, Walker EA, Rawls SM. Beta-lactam antibiotic decreases acquisition of and motivation to respond for cocaine, but not sweet food, in C57Bl/6 mice. Behav Pharmacol. 2011 Aug;22(4):370-3. doi: 10.1097/FBP.0b013e3283473c10.
Background: PubMed 23031254Kovalevich J, Corley G, Yen W, Rawls SM, Langford D. Cocaine-induced loss of white matter proteins in the adult mouse nucleus accumbens is attenuated by administration of a beta-lactam antibiotic during cocaine withdrawal. Am J Pathol. 2012 Dec;181(6):1921-7. doi: 10.1016/j.ajpath.2012.08.013. Epub 2012 Sep 29.

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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.

Kyle M. Kampman, M.D. principal investigator

U54 Principal Investigator - University of Pennsylvania

Mary F. Morrison, M.D., M.S. principal investigator

Temple University

M. I Walters, M.D. principal investigator

Temple University

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 Clavulanic acid and Intravenous cocaine in people with Cocaine Dependence and Cocaine Addiction, run by Temple University 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 3 inclusion and 2 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 3 Nov 2023. 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?

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?

Yes. Results are posted in the registry (first posted 3 Nov 2023). 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?

Number of Participants With Severe Adverse Events (AEs) (time frame: 6 Days (Study Days 1, 2, 3, 4, 5, 10)). The study lists 4 primary outcomes in all. 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 NCT02563769, which also lists 4 linked publications.

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 3 Nov 2023.