Effects of Diacetylmorphine (DAM) on Brain Function and Stress Response

NCT01174927 | Completed Phase 1 DMC

• 2 other identifiers: DAM2010_01SNF127544
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of the study are to investigate the effects of diacetylmorphin (heroin) on brain using functional magnetic resonance imaging (fMRI), coupled with measurements of cortisol concentrations and neurophysiological stress parameters during the presentation of emotional and cognitive stimuli in patients with heroin dependence.

Conditions

Opiate

Keywords

Substance use disorder; Stress

Outcome Measures

Primary Outcomes (1)

• brain functions

  1 hour

Secondary Outcomes (1)

• stress response

  pre and post stress measurements

Study Arms (2)

Heroin-dependent patients_1

ACTIVE COMPARATOR

daily dose of diacetylmorphine (30 mg to 500 mg) in 5 ml

Drug: diacetylmorphine (DAM)

Heroin-dependent patients_2

PLACEBO COMPARATOR

5 ml saline

Other: Placebo

Interventions

diacetylmorphine (DAM) DRUG

The heroin-dependent patients will administer either their individual dose of prescribed DAM dose or placebo (saline) through an indwelling intravenous line. Afterwards they will complete four experimental paradigms testing response inhibition, emotional processing and working memory while brain responses are measured with fMRI. Before and after the fMRI investigation cortisol samples, DAM blood levels, neurophysiological and psychological stress parameters, such as skin conductance, heart rate, anxiety, anger, and heroin craving will be measured.

Also known as: heroin

Heroin-dependent patients_1

Placebo OTHER

Saline

Heroin-dependent patients_2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• opioid dependence

You may not qualify if:

• other psychiatric disorders

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• University of Bern: collaborator

Study Sites (1)

UPK

Basel, Basel, 4025, Switzerland

Location

Related Links

• clinic homepage

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Heroin

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Marc Walter, MD

  UPK, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 4, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: February 1, 2012
• Last Updated: October 15, 2015

Record last verified: 2015-10

Locations

CH (1)