Glutathione Levels and Compulsivity

NCT02794389 | Completed

• 1 other identifier: R44271/RE001
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will examine whether compulsivity in those who score above-average (but below clinical cut-off) on an eating disorder questionnaire can be altered by 9 days of N-acetyl cysteine (NAC). N-acetyl cysteine has been shown to be of some benefit in individuals with other compulsive disorders, such as trichotillomania and addiction, so this research investigates whether a short period of time taking N-acetyl cysteine changes compulsivity, measured using cognitive tasks and questionnaires.

Conditions

Anorexia Nervosa; Compulsive Behavior

Keywords

Acetylcysteine

Outcome Measures

Primary Outcomes (1)

• Change in scores on the Berg Card-Sort Task (a measure of set-shifting) when taking N-acetyl cysteine compared to placebo

  Improvement in scores on the Berg Card-Sort Task (a version of the Wisconsin Card Sorting Task) after NAC compared to placebo. Analyse using paired-sample t-tests on the perseverative error totals for each participant at each visit.

  Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo.

Secondary Outcomes (10)

• Change in scores on the Attention Switching Task when taking N-acetyl cysteine compared to placebo.

  Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo.

• Change in score on the Affective Go/No-Go task (measuring attentional bias) when taking N-acetyl cysteine compared to placebo

  Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo.

• Change in scores on the Cambridge Gambling Task (measuring disadvantageous decision-making) when taking N-acetyl cysteine compared to placebo

  Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo.

• Change in sequential learning task score (a measure of excessive habit-learning) when taking N-acetyl cysteine compared to placebo.

  Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo.

• Change in scores on delay discounting task when taking N-acetyl cysteine compared to placebo.

  Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo.

Study Arms (2)

N-acetyl cysteine

EXPERIMENTAL

1200mg for 2 days 2400mg for 7 days

Drug: N-acetyl cysteine

Placebo

PLACEBO COMPARATOR

Magnesium stearate capsules

Drug: Placebo

Interventions

N-acetyl cysteine DRUG

N-acetyl cysteine

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study.
• Females aged 18 to 40 years.
• Score between 9 and 19 on the EAT-26.
• Participant is a fluent English speaker

You may not qualify if:

• Any current psychotropic medications.
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the study.
• BMI below 18.5, indicating that they are underweight.
• Any Axis I psychiatric disorder.
• History of allergies to drugs or vaccines or any component of the NAC or placebo capsule (gelatine, magnesium stearate, NAC).
• Pregnant, could be pregnant, breast feeding, or high risk of pregnancy (no reliable contraception use but sexual activity).
• Has taken part in a psychological or medical experiment involving taking any kinds of drugs within the last 6 weeks.
• Has had recent surgery.
• Taking selenium, vitamin E, or NAC.
• Current regular cigarette smoking of over 5 cigarettes per day.

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

Department of Psychiatry, University of Oxford

Oxford, Oxfordshire, OX3 7JX, United Kingdom

Location

Related Publications (8)

• Grant JE, Odlaug BL, Kim SW. A double-blind, placebo-controlled study of N-acetyl cysteine plus naltrexone for methamphetamine dependence. Eur Neuropsychopharmacol. 2010 Nov;20(11):823-8. doi: 10.1016/j.euroneuro.2010.06.018. Epub 2010 Jul 22.

  PMID: 20655182 BACKGROUND

• Grant JE, Kim SW, Odlaug BL. N-acetyl cysteine, a glutamate-modulating agent, in the treatment of pathological gambling: a pilot study. Biol Psychiatry. 2007 Sep 15;62(6):652-7. doi: 10.1016/j.biopsych.2006.11.021. Epub 2007 Apr 18.

  PMID: 17445781 BACKGROUND

• Grant JE, Fineberg N, van Ameringen M, Cath D, Visser H, Carmi L, Pallanti S, Hollander E, van Balkom AJ. New treatment models for compulsive disorders. Eur Neuropsychopharmacol. 2016 May;26(5):877-84. doi: 10.1016/j.euroneuro.2015.11.008. Epub 2015 Nov 18.

  PMID: 26621260 BACKGROUND

• Gillan CM, Kosinski M, Whelan R, Phelps EA, Daw ND. Characterizing a psychiatric symptom dimension related to deficits in goal-directed control. Elife. 2016 Mar 1;5:e11305. doi: 10.7554/eLife.11305.

  PMID: 26928075 BACKGROUND

• Gillan CM, Otto AR, Phelps EA, Daw ND. Model-based learning protects against forming habits. Cogn Affect Behav Neurosci. 2015 Sep;15(3):523-36. doi: 10.3758/s13415-015-0347-6.

  PMID: 25801925 BACKGROUND

• Voon V, Derbyshire K, Ruck C, Irvine MA, Worbe Y, Enander J, Schreiber LR, Gillan C, Fineberg NA, Sahakian BJ, Robbins TW, Harrison NA, Wood J, Daw ND, Dayan P, Grant JE, Bullmore ET. Disorders of compulsivity: a common bias towards learning habits. Mol Psychiatry. 2015 Mar;20(3):345-52. doi: 10.1038/mp.2014.44. Epub 2014 May 20.

  PMID: 24840709 BACKGROUND

• Godier LR, Park RJ. Compulsivity in anorexia nervosa: a transdiagnostic concept. Front Psychol. 2014 Jul 17;5:778. doi: 10.3389/fpsyg.2014.00778. eCollection 2014.

  PMID: 25101036 BACKGROUND

• Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.

  PMID: 34582562 DERIVED

MeSH Terms

Conditions

Anorexia Nervosa; Compulsive Behavior

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Phil J Cowen, Prof

  University of Oxford

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: June 9, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: November 7, 2018

Record last verified: 2018-02

Locations

GB (1)