Investigation of medication-assisted memory activation for intrusive trauma or cocaine memories

Switzerland (ICTRP)

ICTRP Trial ID
NCT05902819 (ICTRP)

Official title (approved by ethics committee)
Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories (BASEC)

Academic title
An Investigation of the Effect of MMP-9 Inhibition With Minocycline on the Reconsolidation of Intrusive Trauma- or Cocaine-related Memories (ICTRP)

Public title
Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories (ICTRP)

Disease under investigation
Post-traumatic Stress DisorderCocaine Use Disorder (ICTRP)

Intervention under investigation
Behavioral: ImageryDrug: MinocyclineDrug: Placebo (ICTRP)

Type of trial
Interventional (ICTRP)

Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator). (ICTRP)

Inclusion/Exclusion criteria
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 (?GT) 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 HCN:

- Any self-reported current psychiatric diagnosis except for mild or moderate SUD for
nicotine (F17.2)

- Self-reported acute intoxication with alcohol or cannabis

- >25 intakes of cocaine, amphetamines, methamphetamine, MDMA, ketamine, psychedelics,
benzodiazepines, other psychotropic substances such as novel psychoactive
substances, non-prescribed opioids or methylphenidate

- Showing signs of acute mental health issues according to the GHQ-12 (Likert scale:
cut-off 12 points)

- Self-reported suicidal ideations in the last 12 months

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 (ICTRP)

not available

Primary and secondary end points
Changes in intrusive memories frequency and features;Change over time in self-reported intrusive memories frequency, arousal and distress;Changes in fMRI Blood-Oxygenation-Level Dependent (BOLD) contrasts;Changes in MRS signal parameters (ICTRP)

Change in heart rate variability (HRV) during fMRI memory reactivation;Change in respiratory rate during fMRI memory reactivation;Change in subjective rating of distress before and after memory reactivation;Change in subjective rating of craving before and after memory reactivation;Change in neurofilament light chain (NfL) levels;Change in sphingolipid levels;Change in inflammatory biomarker levels;Change in MMP-9 protein levels;Change in MMP-9 gene expression;Heartrate variability;Sleep duration;Change in Obsessive Compulsive Cocaine Use Scale (OCCUS);PTSD Checklist for DSM-5 (PCL-5);Beck Depression Inventory-II (BDI-II);Pittsburgh Sleep Quality Index (PSQI);Global Assessment of Functioning (GAF);Clinician-Administered PTSD Scale for DSM-5 (CAPS-5);Changes in the Interview for Psychotropic Drug Consumption (IPDC);Voice-recorded language features of memories (ICTRP)

Registration date
not available

Incorporation of the first participant
not available

Secondary sponsors
University of Zurich (ICTRP)

Additional contacts
Boris B. Quednow, Prof. Dr.;Birgit Kleim, Prof. Dr.;Amelie Zacher, MSc.;Amelie Zacher, ameliesophie.zacher@bli.uzh.ch, +41 58 384 35 54;+41 58 384 35 54, Psychiatric University Hospital Zurich, University of Zurich,Psychiatric University Hospital Zurich, University of Zurich, (ICTRP)

Secondary trial IDs
2022-01177 (ICTRP)

Results-Individual Participant Data (IPD)
not available

Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT05902819 (ICTRP)