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Post-traumatic Stress DisorderMemocyclineNCT05902819

Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories

A study testing Imagery and Minocycline in people with Post-traumatic Stress Disorder and Cocaine Use Disorder, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

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

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

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
What is being tested?
Imagery and Minocycline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
138 participants
Where
1 siteSwitzerland
Study dates
10 May 2023to 2 Mar 2026
Phase
Interventional
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 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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
  • 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
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  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site
  • University Hospital of Psychiatry Zurich, University of Zurich

    Zurich, 8032

Other trials in Switzerland

About this study

Official title: 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

Read the 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.

Being tested
Imagery, Minocycline, Placebo
Keywords
memory reconsolidation blockade, minocycline, MMP-9 inhibition, PTSD, cocaine use disorder, placebo-controlled
Medical subject headings
Stress Disorders, Post-Traumatic, cyclopia sequence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ImageryBehavioural

    Guided imagery of personal trauma- or cocaine-related memory approximately 120min after study medication was given.

  • MinocyclineDrug

    Single dose of minocycline (200mg) at each of two imagery sessions; Minocycline is given orally in form of a capsule.

  • PlaceboDrug

    Single dose of mannitol (100%) at each of two imagery sessions; Placebo is given orally in form of a capsule.

Study groups in NCT05902819
Study groupRoleWhat they receive
PTSD intervention groupExperimental30 individuals with PTSD will receive imagery with minocycline.
Receives: Behavioral: Imagery; Drug: Minocycline
PTSD control groupPlacebo comparator30 individuals with PTSD will receive imagery with placebo.
Receives: Behavioral: Imagery; Drug: Placebo
CUD intervention groupExperimental30 individuals with CUD will receive imagery with minocycline.
Receives: Behavioral: Imagery; Drug: Minocycline
CUD control groupPlacebo comparator30 individuals with CUD will receive imagery with placebo.
Receives: Behavioral: Imagery; Drug: Placebo
Healthy control groupNo intervention30 healthy individuals who will not receive any intervention.
Clinical control groupNo intervention30 individuals with both PTSD and CUD who will not receive any intervention

What is being measured

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

  1. 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.

    Measured: 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)

  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.

    Measured: 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)
  1. Changes in MRS signal parameters

    Glutamate concentrations are measured using MRS in the amygdala in the PTSD group and in the nucleus accumbens in the CUD group.

    Measured: Change from baseline MRS-measured glutamate concentrations after 9 to max. 39 days (follow-up 1).

  2. Changes in fMRI Blood-Oxygenation-Level Dependent (BOLD) contrasts

    fMRI BOLD contrasts between conditions (neutral/stress/trauma for the PTSD group; neutral/reward/drug for the CUD group) and between groups.

    Measured: Changes from baseline fMRI BOLD contrasts after 9 to max. 39 days (follow-up 1).

  3. Change in heart rate variability (HRV) during fMRI memory reactivation

    HRV will be measured during the fMRI cue-reactivity paradigm (listening to trauma- or cocaine-related narratives compared to trauma- and cocaine-unrelated narratives).

    Measured: Change from baseline HRV after 9 to max. 39 days (follow-up 1).

  4. Change in respiratory rate during fMRI memory reactivation

    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).

    Measured: Change from baseline respiratory rate after 9 to max. 39 days (follow-up 1).

  5. Change in subjective rating of distress before and after memory reactivation

    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.

    Measured: Change from baseline subjective distress after 9 to max. 39 days (follow-up 1).

  6. Change in subjective rating of craving before and after memory reactivation

    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.

    Measured: Change from baseline craving after 9 to max. 39 days (follow-up 1).

  7. Change in neurofilament light chain (NfL) levels

    NfL levels will be measured in serum samples.

    Measured: Change from baseline NfL levels after 9 to max. 39 days (follow-up 1).

  8. Change in sphingolipid levels

    Sphingolipid levels will be measured in plasma samples.

    Measured: Change from baseline sphingolipid levels after 9 to max. 39 days (follow-up 1).

  9. Change in inflammatory biomarker levels

    Inflammatory biomarker levels will be measured in serum samples.

    Measured: Change from baseline inflammatory levels after 9 to max. 39 days (follow-up 1).

  10. Change in MMP-9 protein levels

    MMP-9 protein levels will be measured in plasma samples.

    Measured: Change from baseline MMP-9 protein levels after 9 to max. 39 days (follow-up 1).

  11. Change in MMP-9 gene expression

    MMP-9 gene expression will be measured in blood samples.

    Measured: Change from baseline MMP-9 gene expression after 9 to max. 39 days (follow-up 1).

  12. Heartrate variability

    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.

    Measured: Will be measured during 9 to max. 39 days, from baseline until follow-up 1.

  13. Sleep duration

    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.

    Measured: Will be measured during 9 to max. 39 days, from baseline until follow-up 1.

  14. Change in Obsessive Compulsive Cocaine Use Scale (OCCUS)

    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.

    Measured: Change from baseline OCCUS score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).

  15. PTSD Checklist for DSM-5 (PCL-5)

    A 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD in the last 2 weeks prior to the visit.

    Measured: Change from baseline PCL-5 score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).

  16. Beck Depression Inventory-II (BDI-II)

    A 21-item self-report measure for assessing the severity of depression in the last 2 weeks prior to the visit.

    Measured: Change from baseline BDI-II score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).

  17. Pittsburgh Sleep Quality Index (PSQI)

    A 19-item self-report measure which assesses sleep quality and disturbances in the last 2 weeks prior to the visit.

    Measured: Change from baseline PSQI score after both 9 to 39 days (follow-up 1) and approx. 3.5 months (follow-up 2).

  18. Global Assessment of Functioning (GAF)

    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).

    Measured: Change from screening GAF score after both 10 to 50 days (follow-up 1) and approx. 4 months (follow-up 2).

  19. Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)

    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.

    Measured: Change from screening CAPS-5 score after approx. 4 months (follow-up 2).

  20. Changes in the Interview for Psychotropic Drug Consumption (IPDC)

    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.

    Measured: Change from screening IPDC after approx. 4 months (follow-up 2).

  21. Voice-recorded language features of memories

    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.

    Measured: Assessed at screening

Timeline

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

  1. First posted15 Jun 2023
  2. Study start10 May 2023
  3. Primary completion2 Mar 2026
  4. Study completion2 Mar 2026

Resources

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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, placebo-controlled, parallel group, single center study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05902819
Sponsor's protocol ID
2022-01177
Acronym
Memocycline
Status last verified
Mar 2026
First submitted
26 Apr 2023
Last updated
6 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Imagery and Minocycline in people with Post-traumatic Stress Disorder and Cocaine Use Disorder, run by Psychiatric University Hospital, Zurich at 1 site in Switzerland.

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 18 inclusion and 10 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 6 Mar 2026. 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 Switzerland. 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.

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?

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)). The study lists 2 primary outcomes in all. 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 6 Mar 2026.

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