Psychosocial and Medication Treatment for Anxiety in Alcoholism
| Status: | Completed |
|---|---|
| Conditions: | Anxiety, Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 1/26/2018 |
| Start Date: | September 2003 |
| End Date: | March 2009 |
CBT And Venlafaxine Treatments For Anxiety In Alcoholism
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.
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.
Difficulties in anxiety management are frequent causes of relapse to alcohol use. Empirical
data support the role of anxiety in alcohol relapse, and both psychosocial and
pharmacological treatments for alcohol problems increasingly address the role of negative
affect in alcohol-use disorders. Due to the lack of large, well-controlled treatment outcome
trials, the optimal treatment (or combination of treatments) remains unknown. Real world
practice in the treatment of alcohol-use disorders frequently begins with brief
detoxification and stabilization, and is often followed by some combination of CBT and
pharmacotherapy for patients complaining of mood difficulties while attempting early
abstinence from alcohol.
The purpose of the present study is to evaluate the relative benefits of psychosocial and
psychopharmacological therapy for the treatment of co-morbid anxiety and alcohol dependence
among patients attempting early abstinence from alcohol. We will address the following four
questions:
1. During the course of intervention, is treatment of anxiety disorders with combined
treatments of established utility (among non-alcohol-use-disordered patients) superior
in managing both return to drinking and anxiety symptoms than either monotherapy, or a
fully inactive control treatment?
2. During the follow-up period, will patients who received the combined active treatments
fare better in maintaining abstinence relative to the single active treatments, and
those in the control condition?
3. What psychosocial variables (such as increases or lapses to elevated anxiety) mediate
return to pre-treatment levels of alcohol use?
4. Will baseline indices of alcohol dependence and anxiety disorder severity moderate the
relationship between treatment and outcome during both the acute and follow-up phases of
the study?
data support the role of anxiety in alcohol relapse, and both psychosocial and
pharmacological treatments for alcohol problems increasingly address the role of negative
affect in alcohol-use disorders. Due to the lack of large, well-controlled treatment outcome
trials, the optimal treatment (or combination of treatments) remains unknown. Real world
practice in the treatment of alcohol-use disorders frequently begins with brief
detoxification and stabilization, and is often followed by some combination of CBT and
pharmacotherapy for patients complaining of mood difficulties while attempting early
abstinence from alcohol.
The purpose of the present study is to evaluate the relative benefits of psychosocial and
psychopharmacological therapy for the treatment of co-morbid anxiety and alcohol dependence
among patients attempting early abstinence from alcohol. We will address the following four
questions:
1. During the course of intervention, is treatment of anxiety disorders with combined
treatments of established utility (among non-alcohol-use-disordered patients) superior
in managing both return to drinking and anxiety symptoms than either monotherapy, or a
fully inactive control treatment?
2. During the follow-up period, will patients who received the combined active treatments
fare better in maintaining abstinence relative to the single active treatments, and
those in the control condition?
3. What psychosocial variables (such as increases or lapses to elevated anxiety) mediate
return to pre-treatment levels of alcohol use?
4. Will baseline indices of alcohol dependence and anxiety disorder severity moderate the
relationship between treatment and outcome during both the acute and follow-up phases of
the study?
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Participant is a member of the same household of another subject already participating
in the study
- Participant is legally mandated (e.g., to avoid incarceration, monetary or other
penalties, etc.) to participate in an alcohol treatment program
- Participant has a current or recent (past 30 days) DSM-IV diagnosis of other substance
abuse or dependence, with the exception of nicotine, marijuana, and caffeine
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