NCT00967005

Brief Summary

The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and pathological gamblers (PG) symptoms in nicotine dependent pathological gamblers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 25, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 27, 2009

Completed
5 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 7, 2017

Completed
Last Updated

March 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 years

First QC Date

August 25, 2009

Results QC Date

April 3, 2017

Last Update Submit

February 21, 2023

Conditions

GamblingTobacco Use Disorder

Keywords

N acetyl cysteinePathological gamblingNicotine dependence

Outcome Measures

Primary Outcomes (24)

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score

    Week 0 corresponds to baseline. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.

    Week 0

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score

    Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.

    Week 6

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score

    Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.

    Week 12

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Total Score

    Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Minimum score=0 and maximum score=40, with higher score signifying more severe symptoms. Scale is 10 items scored from 0 to 4. Scores on each item are summed to compute total score. Thoughts/urges (questions 1 to 5) and behavior (questions 6 to 10) are added to get the total score.

    Week 24

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale

    Week 0 corresponds to baseline. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.

    Week 0

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale

    Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.

    Week 6

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale

    Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.

    Week 12

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Urges/Thoughts Subscale

    Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 1 through 5 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe thoughts/urges.

    Week 24

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale

    Week 0 corresponds to baseline. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.

    Week 0

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale

    Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. . Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.

    Week 6

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale

    Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.

    Week 12

  • Yale-Brown Obsessive Compulsive Scale Modified for Pathological Gambling Behavior Subscale

    Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). Questions 6 through 10 are summed to compute the thoughts/urges subscale. Minimum=0 and maximum=20, with higher scores signifying more severe gambling behaviors.

    Week 24

  • Fagerstrom Test for Nicotine Dependence Total Score

    Week 0 corresponds to baseline. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.

    Week 0

  • Fagerstrom Test for Nicotine Dependence Total Score

    Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.

    Week 6

  • Fagerstrom Test for Nicotine Dependence Total Score

    Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.

    Week 12

  • Fagerstrom Test for Nicotine Dependence Total Score

    Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale has 6 questions. Questions 1 and 4 are on a scale from 0 to 3 (higher scores being more severe symptoms) and questions 2, 3, 5, and 6 are on a scale from 0 to 1 (1 being more severe symptoms). Scores on all questions are summed to compute total score, with higher total score meaning more severe nicotine dependence. Scores range from 0 to 10.

    Week 24

  • Hamilton Depression Rating Scale Total Score

    Week 0 corresponds to baseline. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.

    Week 0

  • Hamilton Depression Rating Scale Total Score

    Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.

    Week 6

  • Hamilton Depression Rating Scale Total Score

    Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.

    Week 12

  • Hamilton Depression Rating Scale Total Score

    Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale assesses depressed mood, feelings of guilt, difficulty sleeping, somatic symptoms, and others. Total score is computed by summing the scores of the 17 items. Minimum score is 0 and maximum score is 52, with higher scores signifying more severe depressive symptoms.

    Week 24

  • Hamilton Anxiety Rating Scale Total Score

    Week 0 corresponds to baseline. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.

    Week 0

  • Hamilton Anxiety Rating Scale Total Score

    Week 6 corresponds to end of N-acetylcysteine plus Ask-Advise-Refer therapy versus placebo plus Ask-Advise-Refer therapy. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.

    Week 6

  • Hamilton Anxiety Rating Scale Total Score

    Week 12 corresponds to end of 6 sessions of N-acetylcysteine plus imaginal desensitization and motivational interviewing versus placebo plus imaginal desensitization and motivational interviewing. This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.

    Week 12

  • Hamilton Anxiety Rating Scale Total Score

    Week 24 represents the 3-month follow-up period (ie, corresponds to being off N-acetylcysteine or placebo and done with imaginal desensitization and motivational interviewing for 12 weeks). This scale measures anxiety symptoms, tension, somatic symptoms, difficulty concentrating, and others. Total score is computed by summing the scores on the 14 items (each item is scored from 0 to 4). Minimum score= 0 and maximum score= 56, with higher scores signifying more severe anxiety symptoms.

    Week 24

Study Arms (2)

N Acetyl Cysteine

EXPERIMENTAL

The objective of this application is to examine whether, given its mechanism of action, the dietary supplement, N-acetyl cysteine (NAC) will reduce both tobacco use and PG symptoms in nicotine dependent pathological gamblers.

Drug: N Acetyl Cysteine

Sugar Pill

PLACEBO COMPARATOR
Other: Sugar Pill

Interventions

N Acetyl CysteineDRUG

N-Acetyl Cysteine, 1200mg-3000mg each day for 24-weeks

Also known as: N-acetylcysteine, Acetylcysteine, NAC
N Acetyl Cysteine
Sugar PillOTHER

placebo control

Sugar Pill

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female outpatients, age 18-75 years;
  • Presence of current DSM-IV nicotine dependence and PG for at least 6 months duration;
  • Stable psychotropic drug dose for a period of at least 3 months prior to study entry;
  • Completion of complete blood count, urinalysis, liver function tests, thyroid function tests, and pregnancy test with no evidence of significant lab abnormalities;
  • Signed informed consent

You may not qualify if:

  • Subjects who are currently receiving individual or group therapy specifically for nicotine dependence or PG symptoms;
  • Currently receiving pharmacotherapies for either nicotine dependence or pathological gambling;
  • Subjects who have started attending Gamblers Anonymous within the 3 months prior to study initiation;
  • Subjects who have an unstable and significant medical illness;
  • Current clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale) or any other disorder requiring immediate intervention;
  • Lifetime history of bipolar disorder type I or II, dementia, or psychotic disorder;
  • Current (past 12 months) DSM-IV substance abuse or dependence (except nicotine dependence);
  • Borderline or antisocial personality disorder based on the SCID-II;
  • Positive urine drug screen at screening;
  • Asthma (given possible worsening of asthma due to NAC);
  • Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent;
  • Current pregnancy or lactation, or inadequate contraception in women of childbearing potential; and
  • Previous treatment with NAC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

University of Minnesota School of Medicine

Minneapolis, Minnesota, 55454, United States

Location

Related Publications (3)

  • Dowling N, Merkouris S, Lubman D, Thomas S, Bowden-Jones H, Cowlishaw S. Pharmacological interventions for the treatment of disordered and problem gambling. Cochrane Database Syst Rev. 2022 Sep 22;9(9):CD008936. doi: 10.1002/14651858.CD008936.pub2.

    PMID: 36130734DERIVED

  • Grant JE, Odlaug BL, Chamberlain SR, Potenza MN, Schreiber LR, Donahue CB, Kim SW. A randomized, placebo-controlled trial of N-acetylcysteine plus imaginal desensitization for nicotine-dependent pathological gamblers. J Clin Psychiatry. 2014 Jan;75(1):39-45. doi: 10.4088/JCP.13m08411.

    PMID: 24345329DERIVED

  • Potenza MN, Balodis IM, Franco CA, Bullock S, Xu J, Chung T, Grant JE. Neurobiological considerations in understanding behavioral treatments for pathological gambling. Psychol Addict Behav. 2013 Jun;27(2):380-92. doi: 10.1037/a0032389. Epub 2013 Apr 15.

    PMID: 23586456DERIVED

MeSH Terms

Conditions

GamblingTobacco Use Disorder

Interventions

AcetylcysteineSugars

Condition Hierarchy (Ancestors)

Risk-TakingBehaviorDisruptive, Impulse Control, and Conduct DisordersMental DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and ProteinsCarbohydrates

Results Point of Contact

Title
Dr. Marc N. Potenza, M.D., Ph.D.
Organization
Yale University
marc.potenza@yale.edu
203-737-3553

Study Officials

  • Marc N Potenza, MD, PhD

    Yale University

    PRINCIPAL INVESTIGATOR

  • Jon E Grant, MD, JD, MPH

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2009

First Posted

August 27, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2012

Study Completion

August 1, 2014

Last Updated

March 21, 2023

Results First Posted

July 7, 2017

Record last verified: 2023-02

Locations

US(2)