Psychosocial and Medication Treatment for Anxiety in Alcoholism

NCT00248612 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: H-22529R01AA013727-01A1
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed project is written as a "typical clinical practice" test and is a fully-controlled trial of a combined anxiety-focused CBT and pharmacotherapy (venlafaxine; CBT-VEN) delivered for patients with comorbid alcohol-use and anxiety disorders. The CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication. One hundred and eighty participants will be recruited and, subsequent to a platform of outpatient treatment for alcoholism, will be randomly assigned to a 12-week treatment condition. All treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo. The treatments will conclude with a 2-week medication/placebo taper. Follow-up assessments will be conducted at post-treatment and at 3, 6, 9, and 12-months. The long-term objectives of this research are to develop a real-world combination of psychosocial and pharmacological treatments for patients with comorbid alcohol-use and anxiety disorders that compromise prognosis, and to evaluate the effectiveness of combined psychosocial and pharmacological treatments that target anxiety among patients with this comorbidity.

Conditions

Alcohol-Related Disorders; Anxiety Disorders

Keywords

Venlafaxine; Alcoholism; Anxiety Disorders; Alcohol-Use Disorders; Alcohol Abuse; Alcohol Dependence; Cognitive Behavioral Treatment

Outcome Measures

Primary Outcomes (4)

• Clinical Global Impression Scale-I (CGI-I)

  Global improvement of alcohol dependence: Rate the total improvement in the participant's alcohol dependence symptoms whether or not, in your judgment, it is due entirely to treatment. Compared to his/her admission to the project, how much has s/he changed? (1-Not assessed, first rating, 2-Very much improved, 3-Much improved, 4-Minimally improved, 5-Unchanged, 6-Minimally worse, 7-Much worse, 8-Very much worse)

  Session 1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)

• Clinical Global Impression Scale-S (CGI-S)

  Global severity of alcohol dependence: Considering your total clinical experience with the alcohol dependent population how severe are his/her alcohol dependence symptoms at this time? (1-Normal, no symptoms, 2-Borderline symptoms, 3-Mild symptoms, 4-Moderate symptoms, 5-Marked symptoms, 6-Severe symptoms, 7-Among the most extreme symptoms)

  1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)

• Craving Desire Scale (CDS)

  The Craving Desire Scale (CDS) is a 3-item scale ("1. I do want to drink now", "2. I crave a drink right now", 3. "I have a desire for a drink right now") used to identify the degree of current alcohol craving, with responses provided on a Likert scale of 1-7: with 1 meaning strongly disagree, and 7 meaning strongly agree to each of the 3 items. Total scores can range from 3 to 21 with higher scores indicating greater craving for alcohol.

  1 (Baseline) , Session 8 (8 weeks of treatment), Session 11 (11 weeks of treatment)

• Number of Participants Abstinent

  Abstaining from the consumption of intoxicating beverages.

  Session 8 (8 weeks of treatment)

Secondary Outcomes (5)

• Treatment Completion

  12 months

• Medication Compliance Rates

  12 months

• DASS Stress Subscale Score

  Session 1 (baseline), Session 11 (11 weeks of treatment)

• HAM-A Scale

  Session 1 (baseline), Session 8 (8 weeks of treatment)

• HAM-D Scale

  Session 1 (baseline), Session 8 (8 weeks of treatment)

Study Arms (4)

Venlafaxine & CBT

EXPERIMENTAL

CBT is Cognitive Behavioral Treatment which will be tailored to participants. Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.

Drug: Venlafaxine; Behavioral: CBT

Placebo & CBT

ACTIVE COMPARATOR

CBT is Cognitive Behavioral Treatment which will be tailored to participants.For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.

Behavioral: CBT; Other: Placebo medication

Venlafaxine & PMR

ACTIVE COMPARATOR

Progressive Muscle Relaxation Therapy (PMR) is a technique of alternately tensing and relaxing muscles groups in sequence throughout the body. . Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.

Drug: Venlafaxine; Other: Progressive muscle relaxation therapy (PMR)

Placebo & PMR

PLACEBO COMPARATOR

Progressive Muscle Relaxation Therapy (PMR) is a technique of alternately tensing and relaxing muscles groups in sequence throughout the body. . For patients with co-morbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.

Other: Progressive muscle relaxation therapy (PMR); Other: Placebo medication

Interventions

Venlafaxine DRUG

Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine. The treatments will conclude with a 2-week medication taper.

Also known as: Effexor XR

Venlafaxine & CBT; Venlafaxine & PMR

CBT BEHAVIORAL

CBT is Cognitive Behavioral Therapy. Participants will be assigned to a 12-week treatment condition; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial. The treatments will conclude with a 2-week medication/placebo taper.

Placebo & CBT; Venlafaxine & CBT

Progressive muscle relaxation therapy (PMR) OTHER

For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.

Placebo & PMR; Venlafaxine & PMR

Placebo medication OTHER

For patients with comorbid alcohol-use and anxiety disorders, CBT and pharmacotherapy will be contrasted with relaxation training and placebo medication; all treatment conditions will begin with a 1-week placebo run-in, after which participants will begin a trial of venlafaxine or placebo.

Placebo & CBT; Placebo & PMR

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be English-speaking males or females
• Participants must be between 18 and 65 years old
• Meet criteria for DSM-IV diagnosis of alcohol abuse or dependence
• Meet criteria for Panic disorder, Social Phobia or Generalized Anxiety Disorder
• Physically able to attend sessions at the Counseling Center
• Able to read and write
• Able to complete the structured interview and self-report assessment packet
• Able to attend all treatment sessions and follow-up assessments
• Able to sign a witnessed informed consent form
• Participants express a desire to completely stop drinking alcohol or reduce alcohol consumption with the possible long-term goal of abstinence

You may not qualify if:

• Meet DSM-IV diagnostic criteria for bipolar disorder, schizophrenia, bulimia/anorexia, or dementia
• Currently taking anti-craving agents (e.g. Naltrexone, methadone)
• Currently taking medication that has clinically significant interactions with venlafaxine
• Previous use of venlafaxine
• Currently taking other antidepressant medications
• Currently taking medication known to decrease anxiety or alcohol consumption (e.g. antabuse)
• Currently prescribed medications with known abuse potential (e.g., subjects on opioid agonist therapy)
• Currently prescribed medications as a sleep aid (e.g. Ambien)
• Currently taking herbal supplements that have been shown to interact with venlafaxine or affect anxiety symptoms
• Currently pregnant, breastfeeding, plans of becoming pregnant during the course of the study, or not using medically acceptable form of birth control (oral contraceptives, barrier \[diaphragm or condom\] with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection).
• Planning to relocate out-of-state within four months of protocol initiation
• History of psychotic symptoms within the past 30 days
• Experiencing severe symptoms of depression or have engaged in suicidal behaviors within the past 30 days
• Medical contraindications to the use of venlafaxine \[severe renal disease, cirrhosis, uncontrolled blood pressure, recent cardiovascular problems (e.g., heart attack), and seizure disorders; currently taking a monoamine oxidase inhibitor, MAOI\]
• Self-reported anxiety less than 15 on the Hamilton Rating Scale for Anxiety

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (2)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Center for Anxiety and Related Disorders

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Alcohol-Related Disorders; Anxiety Disorders; Alcoholism

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Limitations and Caveats

Small size of treatment groups leading to diminished meaningful difference between comparison groups at follow-up; Failure of randomization leading to unequal number of subjects in each treatment group.

Results Point of Contact

• Title: Todd J. Farchione, PhD
• Organization: Center for Anxiety and Related Disorders at Boston University

tfarchio@bu.edu

617 353 9610

Study Officials

• Domenic Ciraulo, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 4, 2005
• Study Start: September 1, 2003
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 24, 2018
• Results First Posted: August 17, 2017

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)