Phase 3
N=81
Psychosocial and Medication Treatment for Anxiety in Alcoholism
Alcohol-Related Disorders · Anxiety Disorders
Bottom Line
View on ClinicalTrials.gov: NCT00248612 ↗Enrolled (actual)
81
Serious AEs
8.6%
Results posted
Aug 2017
Primary outcome: Primary: Clinical Global Impression Scale-I (CGI-I) — 3.65; 3.81; 3.86; 4.05 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Venlafaxine (Drug); CBT (Behavioral); Progressive muscle relaxation therapy (PMR) (Other); Placebo medication (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Global Impression Scale-I (CGI-I) |
3.65; 3.81; 3.86; 4.05; 3.61; 3.13 | — |
| PRIMARY Clinical Global Impression Scale-S (CGI-S) |
4.00; 3.76; 3.93; 4.18; 3.28; 2.88 | — |
| PRIMARY Craving Desire Scale (CDS) |
8.63; 8.14; 8.21; 7.55; 6.44; 7.41 | — |
| PRIMARY Number of Participants Abstinent |
2; 4; 3; 1 | — |
| SECONDARY Treatment Completion |
18; 17; 11; 15 | — |
| SECONDARY Medication Compliance Rates |
96.89; 97.06; 88.70; 95.39 | — |
| SECONDARY DASS Stress Subscale Score |
16.7; 19.2; 21.5; 16.6; 8.1; 9.6 | — |
| SECONDARY HAM-A Scale |
13.5; 14.2; 16.5; 12.9; 9.8; 9.1 | — |
| SECONDARY HAM-D Scale |
12.0; 11.7; 13.0; 13.6; 8.8; 8.5 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00248612). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.