Reconsolidation Blockade of Intrusive Trauma- and Cocaine-related Memories

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-10

Study Completion Date

2026-03-14

Brief Summary

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

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Detailed Description

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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.

Conditions

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Post-traumatic Stress Disorder Cocaine Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, placebo-controlled, parallel group, single center study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

double-blinded

Study Groups

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PTSD intervention group

30 individuals with PTSD will receive imagery with minocycline.

Group Type EXPERIMENTAL

Imagery

Intervention Type BEHAVIORAL

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

Minocycline

Intervention Type DRUG

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

PTSD control group

30 individuals with PTSD will receive imagery with placebo.

Group Type PLACEBO_COMPARATOR

Imagery

Intervention Type BEHAVIORAL

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

Placebo

Intervention Type DRUG

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

CUD intervention group

30 individuals with CUD will receive imagery with minocycline.

Group Type EXPERIMENTAL

Imagery

Intervention Type BEHAVIORAL

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

Minocycline

Intervention Type DRUG

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

CUD control group

30 individuals with CUD will receive imagery with placebo.

Group Type PLACEBO_COMPARATOR

Imagery

Intervention Type BEHAVIORAL

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

Placebo

Intervention Type DRUG

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

Healthy control group

30 healthy individuals who will not receive any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Clinical control group

30 individuals with both PTSD and CUD who will not receive any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Healthy control group for memory narratives

30 healthy individuals who will not receive any intervention, who undergo an online memory assessment only to improve comparability of text-based language features between healthy controls and participants with a PTSD or CUD diagnosis (HCN group)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Imagery

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

Intervention Type BEHAVIORAL

Minocycline

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)

* 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

* 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)
* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes