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Completed

NCT Number: NCT00721526

Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

The proposed design is a single-group open-label trial. Qualified consenting participants with active alcohol dependence and primary or secondary anxiety disorder will receive monitored disulfiram and lorazepam, in the context of a structured Medication Management (MM) model. In weeks 9-15 lorazepam is tapered, and disulfiram is stopped at the end of week 16. Participants who achieve 4 weeks abstinence and meet criteria for a primary anxiety disorder or mood disorder may receive ancillary medication consisting FDA-approved non-benzodiazepine treatment, with specific options for each disorder described in the protocol. Participants requiring continued treatment are referred to clinical treatment in the community at week 16, and bridging prescriptions of anxiolytic/antidepressant medication may be provided. A final follow-up assessment occurs at week 28. The primary outcomes are Percent Days Abstinent (PDA) and retention in treatment. Secondary alcohol outcomes are consequences, drinks per drinking day, remission status, and time to first heavy drinking day. Anxiety outcomes are Hamilton Anxiety Scale scores and anxiety disorder diagnosis.

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Key information

Conditions

Alcohol Dependence Alcohol-Related Disorders Alcoholism Anxiety Disorder Anxiety Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of New Mexico Addiction and Substance Abuse Programs

Albuquerque, New Mexico, 87106, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females age 18 and over with alcohol dependence.
  • Able to provide voluntary informed consent.
  • At least 4 heavy drinking days in the past 30 days.
  • Primary or secondary anxiety disorder, including diagnoses of generalized anxiety disorder, panic disorder, social phobia, PTSD, obsessive-compulsive disorder, alcohol-induced anxiety disorder, or anxiety disorder not otherwise specified, ascertained by the SCID.
  • Goal of abstinence.
  • 2 days abstinence at the time of study entry (did not drink yesterday or today).
  • Willing to come to clinic 3x/week.
  • If female of child-bearing potential, willing to use approved method of contraception.

Exclusion criteria

  • Moderate or severe withdrawal (CIWA-A greater than 15), history of withdrawal seizures or delirium tremens.
  • Medical conditions (seizure disorder, sleep apnea, significantly impaired liver function, chronic or acute nephritis, symptomatic coronary artery disease, acute narrow-angle glaucoma).
  • Urine drug screen positive for opioids or barbiturates.
  • Hypersensitivity to thiuram derivatives.
  • Pregnancy.
  • Laboratory abnormalities (any LFT greater than 3 times normal, ECG evidence of ischemia, UA suggestive of nephritis, serious abnormalities of CBC).
  • Need to take excluded medication (e.g. amprenavir oral solution, diazoxide oral suspension, isoniazid, lopinavir/ritonavir oral solution, metronidazole, omeprazole, phenytoins, ritonavir, tinidazole, tipranavir, warfarin, azelastine, sodium oxybate).
  • Psychiatric conditions (schizophrenia, schizoaffective disorder, bipolar disorder; opioid dependence, benzodiazepine or other sedative hypnotic dependence).

Treatment and study plan

disulfiram plus lorazepam

Drug

Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily

Primary outcomes

  1. Treatment Adherence

    Time frame: 16 weeks

    Completion of 16 weeks of disulfiram treatment

Secondary outcomes

  1. Percent Days Abstinent From Alcohol (Intent-to-treat Sample)

    Time frame: Weeks 13-16 (Last 4 weeks of treatment)

    As measured by Timeline Followback

  2. Categorical Abstinence (Intent-to-treat Sample)

    Time frame: Weeks 13-16 (Last 4 weeks of treatment)

    As measured by timeline followback

  3. Percent Days Abstinent From Alcohol (Among Participants Observed at Week 16)

    Time frame: Weeks 13-16 (Last 4 weeks of treatment)

    As measured by Timeline Followback

  4. Categorical Abstinence (Among Those Observed at Week 16)

    Time frame: Weeks 13-16 (Last 4 weeks of treatment)

    As measured by timeline followback

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Disulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jul 24, 2008
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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