Memory ImpairmentPhase 1NCT02193269
The Effects of Minocycline in Humans
A Phase 1 study testing Sugar pill and Minocycline in people with Memory Impairment, run by Yale University at 1 site in United States.
Trial summary
To determine minocycline's effects on cognitive performance and measures of mood in abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric oxide (NO) production. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Memory Impairment
- What is being tested?
- Sugar pill and Minocycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2013to 5 Nov 2015
- 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 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and females, between the ages of 21 and 50 who fulfill criteria for past cocaine dependence according to DSM-IV criteria;
- No cocaine use for the past 30 days;
- No other current dependence or abuse of other drugs of abuse or alcohol (except cocaine and tobacco);
- No current medical problems and normal ECG;
- For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.
Who cannot join
- current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
- history of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
- Liver function tests (ALT or AST) greater than 3 times normal.
- Allergy to minocycline or other tetracyclines.
Trial locations and contacts
1 site in 1 country.
United States1 site
Veteran Affairs Hospital
West Haven, Connecticut, 06516
About this study
Official title: Cognitive Effects of Minocycline in Humans
To determine minocycline's effects on cognitive performance and measures of mood in abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric oxide (NO) production. Previous animal and human studies suggest that minocycline may have utility as a treatment for cocaine addiction.
Read the detailed description
We are proposing a randomized, double-blind, crossover study. A total of 40 male and or female subject completers will have two 4-day treatment periods, in which they will be randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment period, subjects will have daily clinic visits for medication administration and monitoring of adverse events. On Day 4, subjects will have an experimental session in which measures of mood and cognitive performance will be obtained. Following a washout period, ranging from 5 to 15 days, subjects will be crossed over to the alternative treatment.
This study began July 2013; currently 7 subjects were randomized with 5 completers and two drop outs. This study is in data analysis phase.
- Conditions
- Memory Impairment
- Being tested
- Sugar pill, Minocycline
- Keywords
- Abstinent cocaine users, minocycline, antibiotic
- Medical subject headings
- Memory Disorders, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar pillDrug
Also called sugar pill, placebo
you will receive 0.0 mg as a single daily dose for 4 days
MinocyclineDrug
Also called tetracycline antibiotic
you will receive 200 mg as a single daily dose for 4 days
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | 0.0mg Receives: Drug: Minocycline |
| Minocycline | Active comparator | 200mg Receives: Drug: Sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rapid Visual information Processing
Cognitive Test to determine the speed of Visual information
Measured: 2 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study start8 Jul 2013
- Primary completion5 Nov 2015
- Study completion5 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ImpairmentStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Sofuoglu, Yale University
- Investigators
- Mehmet Sofuoglu, M.D.,Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02193269
- Sponsor's protocol ID
- 1304011871
- Status last verified
- Sep 2019
- First submitted
- 14 Jul 2014
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Effects of Minocycline in Humans
- ClinicalTrials.gov ID
- NCT02193269
- Acronym / sponsor ID
- 1304011871
- Conditions
- Memory Impairment
- Keywords
- Abstinent cocaine users, minocycline, antibiotic
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- 8 Jul 2013 (actual)
- Primary completion
- 5 Nov 2015 (actual)
- Study completion
- 5 Nov 2015 (actual)
- First posted
- 17 Jul 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.
To determine minocycline's effects on cognitive performance and measures of mood in abstinent cocaine users. Minocycline is a tetracycline derivative antibiotic that also inhibits microglia activation and the release of pro-inflammatory cytokines, chemokines, and nitric oxide (NO) production. Previous animal and human studies suggest that minocycline may have utility as a treatment for cocaine addiction.
Detailed description
We are proposing a randomized, double-blind, crossover study. A total of 40 male and or female subject completers will have two 4-day treatment periods, in which they will be randomized to minocycline (200 mg/day) or placebo. During the first 3 days of each treatment period, subjects will have daily clinic visits for medication administration and monitoring of adverse events. On Day 4, subjects will have an experimental session in which measures of mood and cognitive performance will be obtained. Following a washout period, ranging from 5 to 15 days, subjects will be crossed over to the alternative treatment.
This study began July 2013; currently 7 subjects were randomized with 5 completers and two drop outs. This study is in data analysis phase.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Drug: Minocycline0.0mg |
| Minocycline | Active comparator | Drug: Sugar pill200mg |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and females, between the ages of 21 and 50 who fulfill criteria for past cocaine dependence according to DSM-IV criteria;
- No cocaine use for the past 30 days;
- No other current dependence or abuse of other drugs of abuse or alcohol (except cocaine and tobacco);
- No current medical problems and normal ECG;
- For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.
Key exclusion criteria (5 listed)
- current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
- history of major medical illnesses; including liver diseases, heart disease, or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study
- Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants) or drugs that would be expected to have major interactions with drugs to be tested, e.g., benzodiazepines, codeine, percocet, and other opiate drugs that will interact with methadone.
- Liver function tests (ALT or AST) greater than 3 times normal.
- Allergy to minocycline or other tetracyclines.
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 |
|---|---|---|
| Sugar pillAlso: sugar pill, placeboyou will receive 0.0 mg as a single daily dose for 4 days | Drug | Minocycline |
| MinocyclineAlso: tetracycline antibioticyou will receive 200 mg as a single daily dose for 4 days | Drug | sugar pill |
Primary outcome
Rapid Visual information Processing
Time frame: 2 yrs
Cognitive Test to determine the speed of Visual information
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 19 Sep 2019.
- 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.
Mehmet Sofuoglu, M.D.,Ph.D. principal investigator
Yale 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 Sugar pill and Minocycline in people with Memory Impairment, run by Yale 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 5 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 19 Sep 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?
Rapid Visual information Processing (time frame: 2 yrs). 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 19 Sep 2019.