NCT01638377

Brief Summary

This pilot study will explore the ways to link Ontario's remedial system for convicted drinking drivers to medical intervention, assess the receptiveness of the Back on Track client population to effective medical interventions, and assess the feasibility of a full-scale trial of pharmacotherapy for convicted drinking drivers.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
terminated

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

June 28, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

1.6 years

First QC Date

June 28, 2012

Last Update Submit

April 1, 2014

Conditions

Alcohol Dependence

Keywords

Back on Trackconvicted drinking driversnaltrexonealcohol dependence

Outcome Measures

Primary Outcomes (1)

  • Participation rate

    We will determine what percentage of subjects will participate in the preliminary medical screening and what percentage of subjects with a diagnosis of alcohol dependence will participate in the trial.

    2 years

Secondary Outcomes (1)

  • Effect of naltrexone on drinking patterns and drinking related measures

    At baseline and six-month follow-up

Study Arms (2)

Naltrexone

EXPERIMENTAL

Drug: Naltrexone 50 mg/day for 24 weeks.All participants will receive medical intervention in the form of medical management (MM) which will be delovered by a trained health care professional.

Drug: Naltrexone

Control

PLACEBO COMPARATOR

Drug: Control Placebo (Lactose Monohydrate) for 24 weeks. All participants will receive medical intervention in the form of medical management (MM) which will be delivered by a trained health care professional.

Drug: Control

Interventions

NaltrexoneDRUG

50 mg/day for 24 weeks. All participants will receive medical intervention in the form of medical management (MM) which will be delivered by a trained health care professional.

Also known as: Revia
Naltrexone
ControlDRUG

Placebo (Lactose Monohydrate) for 24 weeks. All participants will receive medical intervention in the form of medical management (MM) which will be delivered by a trained health care professional.

Also known as: Placebo (Lactose Monohydrate)
Control

Eligibility Criteria

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

You may qualify if:

  • Male or females - 18 years or older
  • Been convicted of drinking driving and allocated to either the education or the treatment group of the BOT program
  • Meet criteria for alcohol dependence using the SCID-IV
  • Consume more than 14 drinks (female) or 21 drinks (male) per week with a minimum of 2 heavy drinking days (≥ 4 drinks for females and ≥ 5 drinks for males) during a consecutive 30-day period within the 90 days prior to the baseline evaluation
  • Willing to receive pharmacotherapy for their alcohol dependence
  • Seeking abstinence from alcohol as their main goal

You may not qualify if:

  • History of other substance use (other than nicotine or cannabis) by DSM-IV criteria in the last 90 days (6 months for opiate abuse)
  • Positive urine drug screen
  • Psychiatric disorder requiring medication
  • Unstable medical condition requiring immediate investigation or treatment
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

Related Publications (15)

  • Anton RF, O'Malley SS, Ciraulo DA, Cisler RA, Couper D, Donovan DM, Gastfriend DR, Hosking JD, Johnson BA, LoCastro JS, Longabaugh R, Mason BJ, Mattson ME, Miller WR, Pettinati HM, Randall CL, Swift R, Weiss RD, Williams LD, Zweben A; COMBINE Study Research Group. Combined pharmacotherapies and behavioral interventions for alcohol dependence: the COMBINE study: a randomized controlled trial. JAMA. 2006 May 3;295(17):2003-17. doi: 10.1001/jama.295.17.2003.

    PMID: 16670409BACKGROUND

  • Lee JD, Grossman E, DiRocco D, Truncali A, Hanley K, Stevens D, Rotrosen J, Gourevitch MN. Extended-release naltrexone for treatment of alcohol dependence in primary care. J Subst Abuse Treat. 2010 Jul;39(1):14-21. doi: 10.1016/j.jsat.2010.03.005. Epub 2010 Apr 2.

    PMID: 20363090BACKGROUND

  • Lapham SC, Smith E, C'de Baca J, Chang I, Skipper BJ, Baum G, Hunt WC. Prevalence of psychiatric disorders among persons convicted of driving while impaired. Arch Gen Psychiatry. 2001 Oct;58(10):943-9. doi: 10.1001/archpsyc.58.10.943.

    PMID: 11576032BACKGROUND

  • Mann RE, Anglin L, Wilkins K, Vingilis ER, MacDonald S. Mortality in a sample of convicted drinking drivers. Addiction. 1993 May;88(5):643-7. doi: 10.1111/j.1360-0443.1993.tb02076.x.

    PMID: 8518714BACKGROUND

  • Impinen A, Makela P, Karjalainen K, Rahkonen O, Lintonen T, Lillsunde P, Ostamo A. High mortality among people suspected of drunk-driving. An 18-year register-based follow-up. Drug Alcohol Depend. 2010 Jul 1;110(1-2):80-4. doi: 10.1016/j.drugalcdep.2010.02.007. Epub 2010 Mar 23.

    PMID: 20334987BACKGROUND

  • COMBINE Study Research Group. Testing combined pharmacotherapies and behavioral interventions in alcohol dependence: rationale and methods. Alcohol Clin Exp Res. 2003 Jul;27(7):1107-22. doi: 10.1097/00000374-200307000-00011.

    PMID: 12878917BACKGROUND

  • Rosner S, Hackl-Herrwerth A, Leucht S, Vecchi S, Srisurapanont M, Soyka M. Opioid antagonists for alcohol dependence. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD001867. doi: 10.1002/14651858.CD001867.pub3.

    PMID: 21154349BACKGROUND

  • Sullivan JT, Sykora K, Schneiderman J, Naranjo CA, Sellers EM. Assessment of alcohol withdrawal: the revised clinical institute withdrawal assessment for alcohol scale (CIWA-Ar). Br J Addict. 1989 Nov;84(11):1353-7. doi: 10.1111/j.1360-0443.1989.tb00737.x.

    PMID: 2597811BACKGROUND

  • Sobell LC, Sobell MB, Leo GI, Cancilla A. Reliability of a timeline method: assessing normal drinkers' reports of recent drinking and a comparative evaluation across several populations. Br J Addict. 1988 Apr;83(4):393-402. doi: 10.1111/j.1360-0443.1988.tb00485.x. No abstract available.

    PMID: 3395719BACKGROUND

  • Tonigan JS, Miller WR, Brown JM. The reliability of Form 90: an instrument for assessing alcohol treatment outcome. J Stud Alcohol. 1997 Jul;58(4):358-64. doi: 10.15288/jsa.1997.58.358.

    PMID: 9203116BACKGROUND

  • Rollnick S, Heather N, Gold R, Hall W. Development of a short 'readiness to change' questionnaire for use in brief, opportunistic interventions among excessive drinkers. Br J Addict. 1992 May;87(5):743-54. doi: 10.1111/j.1360-0443.1992.tb02720.x.

    PMID: 1591525BACKGROUND

  • MacKillop J. Factor structure of the alcohol urge questionnaire under neutral conditions and during a cue-elicited urge state. Alcohol Clin Exp Res. 2006 Aug;30(8):1315-21. doi: 10.1111/j.1530-0277.2006.00159.x.

    PMID: 16899034BACKGROUND

  • Drummond DC, Phillips TS. Alcohol urges in alcohol-dependent drinkers: further validation of the Alcohol Urge Questionnaire in an untreated community clinical population. Addiction. 2002 Nov;97(11):1465-72. doi: 10.1046/j.1360-0443.2002.00252.x.

    PMID: 12410786BACKGROUND

  • HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.

    PMID: 13638508BACKGROUND

  • Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.

    PMID: 8628042RESULT

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Bernard Le Foll, MD, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2012

First Posted

July 11, 2012

Study Start

August 1, 2012

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

CA(1)