NCT02557984

Brief Summary

The purpose of this study is to determine how the dopamine and opioid system is involved in reward processing, specifically in cue-induced reward responding and reward impulsivity, using dopamine and opioid receptor antagonists in healthy participants. The investigators predict that particularly the dopamine challenge should alter cue-induced reward responding and reward impulsivity. Such effects would be of high interest for the treatment of disorders which involve impairments of reward processing such as addiction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2 months

First QC Date

September 14, 2015

Last Update Submit

September 22, 2015

Conditions

Addiction

Keywords

DopamineOpioidReward

Outcome Measures

Primary Outcomes (2)

  • Cue-Induced Reward Responding Measure

    Measured using a Pavlovian-to-Instrumental Transfer Task

    1 day

  • Reward Impulsivity Measure

    Measured using a Delay Discounting Task

    1 day

Secondary Outcomes (1)

  • Mood

    1 day

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo Pill

Drug: Placebo

Amisulpride

EXPERIMENTAL

400 mg Amisulpride (Solian®)

Drug: Amisulpride

Naltrexone

EXPERIMENTAL

50 mg Naltrexone (Naltrexin®)

Drug: Naltrexone

Interventions

PlaceboDRUG

Placebo Pill

Also known as: Lactose Placebo Pill
Placebo
AmisulprideDRUG

400 mg Amisulpride

Also known as: Solian
Amisulpride
NaltrexoneDRUG

50 mg Naltrexone

Also known as: Naltrexin
Naltrexone

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically and psychiatrically healthy men and women

You may not qualify if:

  • Serious past brain disease or injury
  • Pacemaker or neurostimulator
  • Hearing aid
  • Surgery to head or heart
  • Potential metal parts in body (metal splinters, gun wounds, shrapnel or surgical clips)
  • Neurological or psychiatric problems (including alcoholism, depression, schizophrenia, bipolar disorders, anxiety disorder, claustrophobia, or parkinsonian symptoms)
  • High blood pressure, low blood pressure, cardiac attack in anamnesis, irregular heart rate
  • Epilepsy
  • Emphysema, chest problems, or multiple sclerosis
  • Respiratory problems (including difficulty breathing through the nose)
  • Pregnancy, nursing, or planning pregnancy
  • Diabetes
  • Acute Hepatitis
  • Allergy or sensitivity to lactose
  • Allergy or sensitivity to amisulpride or naltrexone
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (9)

  • Arbisi PA, Billington CJ, Levine AS. The effect of naltrexone on taste detection and recognition threshold. Appetite. 1999 Apr;32(2):241-9. doi: 10.1006/appe.1998.0217.

    PMID: 10097028BACKGROUND

  • Gibbs AA, Naudts KH, Spencer EP, David AS. The role of dopamine in attentional and memory biases for emotional information. Am J Psychiatry. 2007 Oct;164(10):1603-9; quiz 1624. doi: 10.1176/appi.ajp.2007.06081241.

    PMID: 17898353BACKGROUND

  • Gonzalez JP, Brogden RN. Naltrexone. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic efficacy in the management of opioid dependence. Drugs. 1988 Mar;35(3):192-213. doi: 10.2165/00003495-198835030-00002.

    PMID: 2836152BACKGROUND

  • Jocham G, Klein TA, Ullsperger M. Dopamine-mediated reinforcement learning signals in the striatum and ventromedial prefrontal cortex underlie value-based choices. J Neurosci. 2011 Feb 2;31(5):1606-13. doi: 10.1523/JNEUROSCI.3904-10.2011.

    PMID: 21289169BACKGROUND

  • Ersche KD, Bullmore ET, Craig KJ, Shabbir SS, Abbott S, Muller U, Ooi C, Suckling J, Barnes A, Sahakian BJ, Merlo-Pich EV, Robbins TW. Influence of compulsivity of drug abuse on dopaminergic modulation of attentional bias in stimulant dependence. Arch Gen Psychiatry. 2010 Jun;67(6):632-44. doi: 10.1001/archgenpsychiatry.2010.60.

    PMID: 20530013BACKGROUND

  • Morein-Zamir S, Craig KJ, Ersche KD, Abbott S, Muller U, Fineberg NA, Bullmore ET, Sahakian BJ, Robbins TW. Impaired visuospatial associative memory and attention in obsessive compulsive disorder but no evidence for differential dopaminergic modulation. Psychopharmacology (Berl). 2010 Oct;212(3):357-67. doi: 10.1007/s00213-010-1963-z. Epub 2010 Jul 27.

    PMID: 20661550BACKGROUND

  • Rukstalis M, Jepson C, Strasser A, Lynch KG, Perkins K, Patterson F, Lerman C. Naltrexone reduces the relative reinforcing value of nicotine in a cigarette smoking choice paradigm. Psychopharmacology (Berl). 2005 Jun;180(1):41-8. doi: 10.1007/s00213-004-2136-8. Epub 2005 Jan 29.

    PMID: 15682300BACKGROUND

  • Lovibond PF, Colagiuri B. Facilitation of voluntary goal-directed action by reward cues. Psychol Sci. 2013 Oct;24(10):2030-7. doi: 10.1177/0956797613484043. Epub 2013 Aug 27.

    PMID: 23982242BACKGROUND

  • Soutschek A, Weber SC, Kahnt T, Quednow BB, Tobler PN. Opioid antagonism modulates wanting-related frontostriatal connectivity. Elife. 2021 Nov 11;10:e71077. doi: 10.7554/eLife.71077.

    PMID: 34761749DERIVED

MeSH Terms

Conditions

Behavior, Addictive

Interventions

AmisulprideNaltrexone

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsNaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Boris B Quednow, Prof

    University Hospital of Psychiatry Zurich

    PRINCIPAL INVESTIGATOR

  • Philippe N Tobler, Prof

    Laboratory for Social and Neural Systems Research, Department of Economics, University of Zurich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2015

First Posted

September 23, 2015

Study Start

February 1, 2014

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

CH(1)