Disulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder

Overview[ - collapse ][ - ]

Purpose 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.
ConditionAlcohol Dependence
Anxiety Disorder
InterventionDrug: disulfiram plus lorazepam
PhasePhase 4
SponsorUniversity of New Mexico
Responsible PartyUniversity of New Mexico
ClinicalTrials.gov IdentifierNCT00721526
First ReceivedJuly 22, 2008
Last UpdatedJanuary 28, 2013
Last verifiedJanuary 2013

Tracking Information[ + expand ][ + ]

First Received DateJuly 22, 2008
Last Updated DateJanuary 28, 2013
Start DateAugust 2009
Estimated Primary Completion DateAugust 2012
Current Primary Outcome Measures
  • Percent days abstinent from alcohol [Time Frame: 16 weeks] [Designated as safety issue: No]
  • retention in treatment [Time Frame: 16 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • drinking consequences [Time Frame: 16 weeks, 24 weeks] [Designated as safety issue: No]
  • Percent days abstinent from alcohol [Time Frame: 24 weeks] [Designated as safety issue: No]
  • drinks per drinking day [Time Frame: 16 weeks, 24 weeks] [Designated as safety issue: No]
  • remission status [Time Frame: 16 weeks, 24 weeks] [Designated as safety issue: No]
  • time to first heavy drinking day [Time Frame: 16 weeks, 24 weeks] [Designated as safety issue: No]
  • Hamilton anxiety scale score [Time Frame: 16 weeks, 24 weeks] [Designated as safety issue: No]
  • adverse events [Time Frame: 16 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitleDisulfiram Combined With Lorazepam for Alcohol Dependence and Anxiety Disorder
Official TitleDisulfiram Combined With Lorazepam for Treatment of Patients With Alcohol Dependence and Primary or Secondary Anxiety Disorder
Brief Summary
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 4
Study DesignEndpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Alcohol Dependence
  • Anxiety Disorder
InterventionDrug: disulfiram plus lorazepam
Disulfiram 500mg three times weekly lorazepam 0.5-2.0 mg three times daily
Study Arm (s)Experimental: Disulfiram plus lorazepam
Disulfiram plus lorazepam

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment45
Estimated Completion DateAugust 2012
Estimated Primary Completion DateAugust 2012
Eligibility Criteria
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).
GenderBoth
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00721526
Other Study ID NumbersNIAAA-BOG_AA016555
Has Data Monitoring CommitteeYes
Information Provided ByUniversity of New Mexico
Study SponsorUniversity of New Mexico
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators Principal Investigator: Michael P. Bogenschutz, M. D. University of New Mexico Health Sciences Center
Verification DateJanuary 2013

Locations[ + expand ][ + ]

University of New Mexico Addiction and Substance Abuse Programs
Albuquerque, New Mexico, United States, 87106