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Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction

Double Blind Placebo Control Opipramol-Baclofen Treatment for Addiction: Medical and Cognitive Effects

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03065998
Enrollment
140
Registered
2017-02-28
Start date
2017-03-31
Completion date
2019-01-31
Last updated
2017-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Abuse

Brief summary

The aim of this study is examining the combination of two FDA approved drugs, Opipramol and baclofen, which may increase rehabilitation from psychoactive substances. Previous studies have indicated a connection of sigma-1 receptor to cocaine abuse and raised the possibility that these receptors as mediators of drug craving . However previous studies showed partial efficacy with no significant relapse in relapse rates. The same is true for the use of GABAb-1 receptor antagonist. Opipramol is a selective agonist for sigma-1 receptor. It is clinically used as an antidepressant and anxiolytic agent. Moreover, previous open and controlled trials indicated that the GABAb-1 antagonist baclofen partial efficacy in suppressing withdrawal symptoms in alcohol addicts and cocaine. Our studies in an animal model for addiction have shown a significant effect of the combine treatment of the indicated medications both in decreasing relapse and increase of -number of respondents.

Interventions

PO

DRUGBaclofen

PO

Sponsors

Ministry of Health, Israel
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Age will be 60-18, both sexes, seeking treatment in order to stop the consumption of materials

Exclusion criteria

* Did not include trial addicts with co-morbidity, kidney, heart, metabolic, neurological and psychiatric disorders (psychosis, chronic depression).

Design outcomes

Primary

MeasureTime frameDescription
Decreased craving1 monthLower withdrawal symptom will be measured by questionnaires

Countries

Israel

Contacts

Primary ContactPaola Roska, MD
paola.roska@MOH.GOV.IL972-2-5080645
Backup ContactKeren Goldman, MsC
keren.goldman@moh.gov.il972-2-5080650

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026