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AddictionNCT02557984

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

A study testing Amisulpride and Naltrexone in people with Addiction, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Addiction
What is being tested?
Amisulpride and Naltrexone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
121 participants
Where
1 siteSwitzerland
Study dates
Feb 2014to Apr 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Physically and psychiatrically healthy men and women

Who cannot join

  • 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)
Show all 19Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

Official title: Dopamine D2/3- and μ-opioid Receptor Antagonists Reduce Cue-induced Reward Responding and Reward Impulsivity in Healthy Volunteers

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.

Read the 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

  1. 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.

Conditions
Addiction
Being tested
Placebo, Amisulpride, Naltrexone
Keywords
Dopamine, Opioid, Reward
Medical subject headings
Behavior, Addictive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Also called Lactose Placebo Pill

    Placebo Pill

  • AmisulprideDrug

    Also called Solian

    400 mg Amisulpride

  • NaltrexoneDrug

    Also called Naltrexin

    50 mg Naltrexone

Study groups in NCT02557984
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo Pill
Receives: Drug: Placebo
AmisulprideExperimental400 mg Amisulpride (Solian®)
Receives: Drug: Amisulpride
NaltrexoneExperimental50 mg Naltrexone (Naltrexin®)
Receives: Drug: Naltrexone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cue-Induced Reward Responding Measure

    Measured using a Pavlovian-to-Instrumental Transfer Task

    Measured: 1 day

  2. Reward Impulsivity Measure

    Measured using a Delay Discounting Task

    Measured: 1 day

Secondary outcomes (1)

  1. Mood

    Current Mood assessed by Visual Analog Scale (VAS)

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2015 (estimated)
  2. Study startFeb 2014
  3. Primary completionApr 2014
  4. Study completionApr 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02557984
Sponsor's protocol ID
SNS_Study_01
Status last verified
Sep 2015
First submitted
14 Sep 2015
Last updated
23 Sep 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 10097028

  • 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.

    PubMed 17898353

  • 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.

    PubMed 2836152

  • 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.

    PubMed 21289169

  • 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.

    PubMed 20530013

  • 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.

    PubMed 20661550

  • 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.

    PubMed 15682300

  • 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.

    PubMed 23982242

  • 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.

    PubMed 34761749

Questions about this trial

What is this clinical trial studying?

A study testing Amisulpride and Naltrexone in people with Addiction, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cue-Induced Reward Responding Measure (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02557984, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.

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