Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories (Memocycline)

March 4, 2026 updated by: Psychiatric University Hospital, Zurich

An Investigation of the Effect of MMP-9 Inhibition With Minocycline on the Reconsolidation of Intrusive Trauma- or Cocaine-related Memories

An investigation of the effect of matrix-metalloproteinase-(MMP)-9 inhibition with minocycline on the reconsolidation of trauma- or cocaine-related memories

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Intrusive memories are involuntary recollections of past emotional events that can become pathological and persist over time, particularly in post-traumatic stress disorder (PTSD) and cocaine use disorders (CUD). Both PTSD and CUD are characterised by a hypersensitivity and -reactivity to cue-elicited memory reactivation and exhibit common neurological alterations, suggesting shared underlying mechanisms. As intrusive memories significantly contribute to maintaining the cycle of relapse in both disorders, it is important to find a way to attenuate them successfully. Research on memory reconsolidation has led to the development of different (pharmacological) approaches to disrupt the process, which have, however, yielded mixed and unspecific effects so far.

The present project aims to investigate the effect of MMP-9 inhibition with minocycline on the reconsolidation of intrusive memories in individuals with CUD or PTSD. Participants will be randomly assigned to a minocycline or placebo group. The study comprises a total of 5 visits during 3 weeks and one follow-up online survey (3 months after the intervention). Participants will receive the study medication before two imagery script-guided memory activation sessions. An ecological momentary assessment (EMA) approach will be employed to track intrusive memories, and glutamate concentration and neural activation will be measured with magnetic resonance spectroscopy (MRS) and functional magnetic resonance (fMRI), respectively, before and after the two imagery sessions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
138

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • University Hospital of Psychiatry Zurich, University of Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

General Inclusion Criteria:

  • Ability to read, understand and provide written informed consent
  • Age between 18 and 60 years
  • To be sufficiently fluent in German

Inclusion Criteria for the PTSD group:

- 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

Inclusion Criteria for the CUD group:

  • 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

Inclusion Criteria for the Clinical Controls (PTSD+CUD group):

  • 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

Exclusion Criteria for the HC, PTSD, CUD, and PTSD+CUD groups:

  • 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

Exclusion Criteria for Healthy Controls:

  • 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)

Exclusion Criteria for both the PTSD and CUD groups:

  • 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

Exclusion Criteria for only the PTSD group:

  • Diagnosis of CUD according to DSM-5 (lifetime)
  • Current diagnosis of severe SUD for nicotine, moderate SUD for alcohol and cannabis, and mild SUD for all other substances according to DSM-5

Exclusion Criteria for only the CUD group:

  • Diagnosis of PTSD according to DSM-5 (lifetime)
  • Current diagnosis of severe SUD for alcohol or cannabis, and mild SUD for all other substances (except for nicotine) according to DSM-5

Exclusion Criteria for Clinical Controls (PTSD+CUD group):

- Current diagnosis of severe SUD for alcohol or cannabis, and mild SUD for all other substances (except for nicotine) according to DSM-5

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PTSD intervention group
30 individuals with PTSD will receive imagery with minocycline.
Behavioral: Imagery
Guided imagery of personal trauma- or cocaine-related memory approximately 120min after study medication was given.
Drug: Minocycline
Single dose of minocycline (200mg) at each of two imagery sessions; Minocycline is given orally in form of a capsule.
Placebo Comparator: PTSD control group
30 individuals with PTSD will receive imagery with placebo.
Behavioral: Imagery
Guided imagery of personal trauma- or cocaine-related memory approximately 120min after study medication was given.
Drug: Placebo
Single dose of mannitol (100%) at each of two imagery sessions; Placebo is given orally in form of a capsule.
Experimental: CUD intervention group
30 individuals with CUD will receive imagery with minocycline.
Behavioral: Imagery
Guided imagery of personal trauma- or cocaine-related memory approximately 120min after study medication was given.
Drug: Minocycline
Single dose of minocycline (200mg) at each of two imagery sessions; Minocycline is given orally in form of a capsule.
Placebo Comparator: CUD control group
30 individuals with CUD will receive imagery with placebo.
Behavioral: Imagery
Guided imagery of personal trauma- or cocaine-related memory approximately 120min after study medication was given.
Drug: Placebo
Single dose of mannitol (100%) at each of two imagery sessions; Placebo is given orally in form of a capsule.
No Intervention: Healthy control group
30 healthy individuals who will not receive any intervention.
No Intervention: Clinical control group
30 individuals with both PTSD and CUD who will not receive any intervention

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in intrusive memories frequency and features
Time Frame: 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)
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
Time Frame: EMA will be conducted for an average of 12 to 42 days (through study participation from baseline to 3 days after follow-up 1).
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in fMRI Blood-Oxygenation-Level Dependent (BOLD) contrasts
Time Frame: Changes from baseline fMRI BOLD contrasts after 9 to max. 39 days (follow-up 1).
fMRI BOLD contrasts between conditions (neutral/stress/trauma for the PTSD group; neutral/reward/drug for the CUD group) and between groups.
Changes from baseline fMRI BOLD contrasts after 9 to max. 39 days (follow-up 1).
Changes in MRS signal parameters
Time Frame: Change from baseline MRS-measured glutamate concentrations after 9 to max. 39 days (follow-up 1).
Glutamate concentrations are measured using MRS in the amygdala in the PTSD group and in the nucleus accumbens in the CUD group.
Change from baseline MRS-measured glutamate concentrations after 9 to max. 39 days (follow-up 1).
Change in heart rate variability (HRV) during fMRI memory reactivation
Time Frame: Change from baseline HRV after 9 to max. 39 days (follow-up 1).
HRV will be measured during the fMRI cue-reactivity paradigm (listening to trauma- or cocaine-related narratives compared to trauma- and cocaine-unrelated narratives).
Change from baseline HRV after 9 to max. 39 days (follow-up 1).
Change in respiratory rate during fMRI memory reactivation
Time Frame: Change from baseline respiratory rate after 9 to max. 39 days (follow-up 1).
Respiratory rate will be measured during the fMRI cue-reactivity paradigm (listening to trauma- or cocaine-related narratives compared to trauma- and cocaine-unrelated narratives).
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
Time Frame: Change from baseline subjective distress after 9 to max. 39 days (follow-up 1).
Current subjective distress will be measured with a visual analogue scale before and after listening to trauma- and cocaine-related narratives compared to trauma- and cocaine-unrelated narratives.
Change from baseline subjective distress after 9 to max. 39 days (follow-up 1).
Change in subjective rating of craving before and after memory reactivation
Time Frame: Change from baseline craving after 9 to max. 39 days (follow-up 1).
Current subjective craving will be measured with the Cocaine Craving Questionnaire (containing ten questions on current craving scaled from 0 to 10) before and after listening to cocaine-related narratives compared to cocaine-unrelated narratives.
Change from baseline craving after 9 to max. 39 days (follow-up 1).
Change in neurofilament light chain (NfL) levels
Time Frame: Change from baseline NfL levels after 9 to max. 39 days (follow-up 1).
NfL levels will be measured in serum samples.
Change from baseline NfL levels after 9 to max. 39 days (follow-up 1).
Change in sphingolipid levels
Time Frame: Change from baseline sphingolipid levels after 9 to max. 39 days (follow-up 1).
Sphingolipid levels will be measured in plasma samples.
Change from baseline sphingolipid levels after 9 to max. 39 days (follow-up 1).
Change in inflammatory biomarker levels
Time Frame: Change from baseline inflammatory levels after 9 to max. 39 days (follow-up 1).
Inflammatory biomarker levels will be measured in serum samples.
Change from baseline inflammatory levels after 9 to max. 39 days (follow-up 1).
Change in MMP-9 protein levels
Time Frame: Change from baseline MMP-9 protein levels after 9 to max. 39 days (follow-up 1).
MMP-9 protein levels will be measured in plasma samples.
Change from baseline MMP-9 protein levels after 9 to max. 39 days (follow-up 1).
Change in MMP-9 gene expression
Time Frame: Change from baseline MMP-9 gene expression after 9 to max. 39 days (follow-up 1).
MMP-9 gene expression will be measured in blood samples.
Change from baseline MMP-9 gene expression after 9 to max. 39 days (follow-up 1).
Heartrate variability
Time Frame: Will be measured during 9 to max. 39 days, from baseline until follow-up 1.
Heartrate variability (measured with a wearable (Fitbit)) predicted by the number and quality of intrusive memories experienced. Overall variability per person, in relation to overall health measured at Screening and Baseline as well as pre- and post-intervention variability will be assessed.
Will be measured during 9 to max. 39 days, from baseline until follow-up 1.
Sleep duration
Time Frame: Will be measured during 9 to max. 39 days, from baseline until follow-up 1.
Sleep duration (in minutes), trajectories over the course of the study periods, clusters of variations in duration and sleep quality (as averaged by the algorithm of Fitbit), according to medication/placebo, number of intrusions and overall health measured at Screening and Baseline.
Will be measured during 9 to max. 39 days, from baseline until follow-up 1.
Change in Obsessive Compulsive Cocaine Use Scale (OCCUS)
Time Frame: Change from baseline OCCUS score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
A 14-item self-report measure that assesses the current inability to control or resist cocaine-related thoughts and behaviors, frequency and impact of thoughts and impulses related to cocaine use, and the degree of interference caused by cocaine related thoughts and behaviors.
Change from baseline OCCUS score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
PTSD Checklist for DSM-5 (PCL-5)
Time Frame: Change from baseline PCL-5 score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD in the last 2 weeks prior to the visit.
Change from baseline PCL-5 score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
Beck Depression Inventory-II (BDI-II)
Time Frame: Change from baseline BDI-II score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
A 21-item self-report measure for assessing the severity of depression in the last 2 weeks prior to the visit.
Change from baseline BDI-II score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change from baseline PSQI score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
A 19-item self-report measure which assesses sleep quality and disturbances in the last 2 weeks prior to the visit.
Change from baseline PSQI score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).
Global Assessment of Functioning (GAF)
Time Frame: Change from screening GAF score after both 10 to 50 days (follow-up 1) and approx. 4 months (follow-up 2).
A numeric scale used by the investigators to rate the current social, occupational, and psychological functioning of a participants. Scores range from 100 (extremely high functioning) to 1 (severely impaired).
Change from screening GAF score after both 10 to 50 days (follow-up 1) and approx. 4 months (follow-up 2).
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
Time Frame: Change from screening CAPS-5 score after approx. 4 months (follow-up 2).
A 30-item structured interview that is used to assess the 20 DSM-5 PTSD symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since the previous CAPS administration, and overall PTSD severity, and specifications for the dissociative subtype.
Change from screening CAPS-5 score after approx. 4 months (follow-up 2).
Changes in the Interview for Psychotropic Drug Consumption (IPDC)
Time Frame: Change from screening IPDC after approx. 4 months (follow-up 2).
A structured interview assessing self-reported patterns of use of common licit and illicit substances during the most representative month of the past year and, in the case of regular cocaine use, also specifically during the past month.
Change from screening IPDC after approx. 4 months (follow-up 2).
Voice-recorded language features of memories
Time Frame: Assessed at screening
Voice features and text-based features of reported autobiographical memories recorded during the screening to predict symptoms, with a primary focus on the prediction of intrusion-related features.
Assessed at screening

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Psychiatric University Hospital, Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-01177

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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