Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories
Memocycline
An Investigation of the Effect of MMP-9 Inhibition With Minocycline on the Reconsolidation of Intrusive Trauma- or Cocaine-related Memories
1 other identifier
interventional
138
1 country
1
Brief Summary
An investigation of the effect of matrix-metalloproteinase-(MMP)-9 inhibition with minocycline on the reconsolidation of trauma- or cocaine-related memories
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 26, 2023
CompletedStudy Start
First participant enrolled
May 10, 2023
CompletedFirst Posted
Study publicly available on registry
June 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2026
CompletedMarch 6, 2026
March 1, 2026
2.8 years
April 26, 2023
March 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Changes in intrusive memories frequency and features
Measured with the Intrusion Questionnaire, containing various items on intrusive memories frequency, arousal and distress as well as triggers, and responses.
Changes from baseline intrusive memories frequency and features after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2)
Change over time in self-reported intrusive memories frequency, arousal and distress
Captured with a short version of the Intrusion Questionnaire implemented as smartphone-based ecological momentary assessment (EMA), containing items on arousal and distress from self-reported intrusive memories.
EMA will be conducted for an average of 12 to 42 days (through study participation from baseline to 3 days after follow-up 1).
Secondary Outcomes (21)
Changes in MRS signal parameters
Change from baseline MRS-measured glutamate concentrations after 9 to max. 39 days (follow-up 1).
Changes in fMRI Blood-Oxygenation-Level Dependent (BOLD) contrasts
Changes from baseline fMRI BOLD contrasts after 9 to max. 39 days (follow-up 1).
Change in heart rate variability (HRV) during fMRI memory reactivation
Change from baseline HRV after 9 to max. 39 days (follow-up 1).
Change in respiratory rate during fMRI memory reactivation
Change from baseline respiratory rate after 9 to max. 39 days (follow-up 1).
Change in subjective rating of distress before and after memory reactivation
Change from baseline subjective distress after 9 to max. 39 days (follow-up 1).
- +16 more secondary outcomes
Study Arms (6)
PTSD intervention group
EXPERIMENTAL30 individuals with PTSD will receive imagery with minocycline.
PTSD control group
PLACEBO COMPARATOR30 individuals with PTSD will receive imagery with placebo.
CUD intervention group
EXPERIMENTAL30 individuals with CUD will receive imagery with minocycline.
CUD control group
PLACEBO COMPARATOR30 individuals with CUD will receive imagery with placebo.
Healthy control group
NO INTERVENTION30 healthy individuals who will not receive any intervention.
Clinical control group
NO INTERVENTION30 individuals with both PTSD and CUD who will not receive any intervention
Interventions
Single dose of mannitol (100%) at each of two imagery sessions; Placebo is given orally in form of a capsule.
Guided imagery of personal trauma- or cocaine-related memory approximately 120min after study medication was given.
Single dose of minocycline (200mg) at each of two imagery sessions; Minocycline is given orally in form of a capsule.
Eligibility Criteria
You may qualify if:
- Ability to read, understand and provide written informed consent
- Age between 18 and 60 years
- To be sufficiently fluent in German
- \- Current diagnosis of full PTSD according to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), of subthreshold PTSD, as in meeting two to three of the DSM-5 criteria B-E, or of complex PTSD
- Current diagnosis of mild, moderate, or severe CUD according to DSM-5
- Regular cocaine use in the last 12 months and at least one consumption event in the last 6 months
- Current diagnosis of full PTSD according to the 5th version of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), of subthreshold PTSD, as in meeting two to three of the DSM-5 criteria B-E, or of complex PTSD
- Current diagnosis of mild, moderate, or severe CUD according to DSM-5
- Regular cocaine use in the last 12 months and at least one consumption event in the last 6 months
You may not qualify if:
- Women who are pregnant or breast feeding or intending to become pregnant during the course of the study or within 3 months after
- Other clinically significant concomitant disease states, e.g., renal failure (i.e., estimated glomerular filtration rate (eGFR; CKD-EPI) lower than 60 ml/min/1.73 m2), hepatic dysfunction (i.e., alanine transaminase (ALT) higher than 90 U/I for women or 110 U/I for men, aspartate aminotransferase (AST) higher than 74 U/I, and/or gamma-glutamyl transferase (γGT) higher than 70 U/I for women or 120 U/I for men), cardiovascular disease, etc.
- Presence or history of severe neurological disorders, head injuries or systemic/rheumatic disease
- Diagnosis of schizophrenia, bipolar disorder, or autism spectrum disorder according to DSM-5
- Pacemaker, neurostimulator or any other head or heart implants as well as MRI-incompatible metal parts or possibility of metal fragments in the body (MR safety)
- Claustrophobia (MR safety)
- Dependence on a hearing aid (MR safety)
- Inability to follow the procedures of the study, e.g., due to language problems
- Participation in another study with investigational drugs within the 30 days preceding and during the present study
- More than three suicide attempts in the past, a suicide attempt within the last 12 months and/or acute suicidality
- Any current psychiatric diagnosis according to DSM-5 except for mild or moderate substance use disorder (SUD) for nicotine, and mild SUD for alcohol and cannabis
- Diagnosis of CUD according to DSM-5 (lifetime)
- Diagnosis of PTSD according to DSM-5 (lifetime)
- Allergy to minocycline or to any other ingredient in the named drug
- Current intake of the following medications interacting with minocycline: acitretin, acetylcystein, aluminiumhydroxid, amitryptiline, any antibiotics, antidiabetic drug such as sulfonylurea, atazanavir, atomoxetine, anticoagulant drugs from the coumarin type, barbiturates, bupropion, carbamazepine, ciclosporin A, isotretinoin, methotrexate, phenytoin, and theophylline
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Psychiatric University Hospital, Zurichlead
- University of Zurichcollaborator
Study Sites (1)
University Hospital of Psychiatry Zurich, University of Zurich
Zurich, 8032, Switzerland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Boris B. Quednow, Prof. Dr.
Psychiatric University Hospital Zurich, University of Zurich
- PRINCIPAL INVESTIGATOR
Birgit Kleim, Prof. Dr.
University Hospital of Psychiatry Zurich, University of Zurich
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- double-blinded
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2023
First Posted
June 15, 2023
Study Start
May 10, 2023
Primary Completion
March 2, 2026
Study Completion
March 2, 2026
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share