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Dopamine and Opioid Receptor Antagonists Reduce Cue-induced Reward Responding and Reward Impulsivity

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ClinicalTrials.gov Identifier: NCT02557984
Recruitment Status : Completed
First Posted : September 23, 2015
Last Update Posted : September 23, 2015
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date  ICMJE September 14, 2015
First Posted Date  ICMJE September 23, 2015
Last Update Posted Date September 23, 2015
Study Start Date  ICMJE February 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
  • Cue-Induced Reward Responding Measure [ Time Frame: 1 day ]
    Measured using a Pavlovian-to-Instrumental Transfer Task
  • Reward Impulsivity Measure [ Time Frame: 1 day ]
    Measured using a Delay Discounting Task
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2015)
Mood [ Time Frame: 1 day ]
Current Mood assessed by Visual Analog Scale (VAS)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dopamine and Opioid Receptor Antagonists Reduce Cue-induced Reward Responding and Reward Impulsivity
Official Title  ICMJE Dopamine D2/3- and μ-opioid Receptor Antagonists Reduce Cue-induced Reward Responding and Reward Impulsivity in Healthy Volunteers
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.
Detailed Description

In this study the investigators use amisulpride and naltrexone to elucidate what function the dopamine and opioid system have in the processing of reward. Amisulpride [Solian®; sanofi-aventis] is an atypical antipsychotic and acts as an antagonist at dopamine D2 and D3 (D2/D3) receptors with very high specificity. Amisulpride has been used in numerous past studies to study the role of dopamine in the brain, for example in studies on reinforcement learning, memory, and attentional bias in stimulant dependence. Naltrexone [Naltrexin®; OrPha Swiss GmbH] is an opioid antagonist and is clinically used in the management of alcohol and opioid dependence. It has been used to investigate the role of opioid in pain perception, taste detection and recognition, and smoking behavior. The investigators were interested in particular how amisulpride and naltrexone influence cue-induced reward responding and reward impulsivity.

Study Aims

A) Investigating the role of the dopamine system in cue-induced reward responding; B) Investigating the role of the dopamine system in reward impulsivity; C) Investigating the role of the opioid system in cue-induced reward responding; A) Investigating the role of the opioid system in reward impulsivity.

Study Design

This is a double-blind, randomized, placebo-controlled, between-subject blocker study. 121 participants received either placebo, the dopamine D2/D3 receptor antagonist amisulpride (400 mg), or the unselective opioid receptor antagonist naltrexone (50 mg), 3h before the experimental tasks. Subjective effects on mood were assessed by visual analogue scales (VAS). Cue-induced reward responding was measured using a standard Pavlovian-to-Instrumental Transfer (PIT) task, where participants press a button for reward in the presence of a stimulus predicting that reward. Reward impulsivity was measured using a Delay Discounting (DD) Task, in which participants choose between smaller, immediate rewards and larger, delayed rewards.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Condition  ICMJE Addiction
Intervention  ICMJE
  • Drug: Placebo
    Placebo Pill
    Other Name: Lactose Placebo Pill
  • Drug: Amisulpride
    400 mg Amisulpride
    Other Name: Solian
  • Drug: Naltrexone
    50 mg Naltrexone
    Other Name: Naltrexin
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Placebo Pill
    Intervention: Drug: Placebo
  • Experimental: Amisulpride
    400 mg Amisulpride (Solian®)
    Intervention: Drug: Amisulpride
  • Experimental: Naltrexone
    50 mg Naltrexone (Naltrexin®)
    Intervention: Drug: Naltrexone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2015)
121
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Physically and psychiatrically healthy men and women

Exclusion Criteria:

  • 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
  • Breast cancer or current tumors
  • Insufficiency of liver or kidney
  • Past use of opiates or other drugs that may interact with amisulpride or naltrexone (such as stimulants)
  • Currently taking medications known to interact with amisulpride or naltrexone (including medicines used to treat irregular heart rhythm such as quinidine, disopyramide, amiodarone and sotalol, cisapride, antibiotics such as erythromycin and pentamidine, levodopa, thioridazone (an antipsychotic), or methadone)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02557984
Other Study ID Numbers  ICMJE SNS_Study_01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: 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
PRS Account University of Zurich
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP