Anxiety DisorderPhase 2NCT00004373
Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
A Phase 2 study testing alprazolam in people with Anxiety Disorder and Panic Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs. II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anxiety Disorder, Panic Disorder
- What is being tested?
- alprazolam
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1997to Mar 2001
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Primary diagnosis of generalized anxiety or panic disorder Determined by Structured Clinical Interview for DSM IV
- Hamilton Anxiety Scale (HAM-A) score at least 14 AND Profile of Mood States (POMS) tension/anxiety scale score at least 20
- Concurrent diagnoses allowed: Mild to moderate agoraphobia Simple or social phobias Secondary unipolar affective disorders
- No current substance abuse, dependence, or substance abuse treatment Drug-free urine sample required
- No history of other primary Axis I diagnosis other than tobacco dependence
--Prior/Concurrent Therapy--
- No prior formalized non-drug therapy for anxiety disorder
- No concurrent prescription psychoactive medication
- No history of benzodiazepine dependence
--Patient Characteristics--
- Age: 18 to 50
- Other: Medically healthy Negative pregnancy test required No occupational requirement to work in hazardous situations
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78284-7811
About this study
OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs.
II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence.
III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients.
IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication.
- Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
Read the detailed description
PROTOCOL OUTLINE: This protocol involves different experiments examining self-medication with anxiolytic medications in selected patients, and cognitive-behavioral therapy for anxiety. Capsules are color coded and taken under double-blind conditions. Compliance is monitored with the Medication Event Monitoring System, which automatically registers the date and time each bottle is opened.
The physician directs therapy administration, using some combination of the following: blind choice test, antianxiety agent(s), placebo, and cognitive-behavioral therapy.
- Conditions
- Anxiety Disorder, Panic Disorder
- Being tested
- alprazolam
- Keywords
- anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease
- Medical subject headings
- Anxiety Disorders, Panic Disorder, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alprazolamDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMar 1997
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of Texas
- Investigators
- John D. Roache, Study chair, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004373
- Sponsor's protocol ID
- 199/11960
- Other IDs
- UTHSC-92120
- Status last verified
- May 2003
- First submitted
- 18 Oct 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
Roache JD, Stanley MA, Creson DR, Shah NN, Meisch RA. Alprazolam-reinforced medication use in outpatients with anxiety. Drug Alcohol Depend. 1997 May 2;45(3):143-55. doi: 10.1016/s0376-8716(97)01354-9.
PubMed 9179516Roache JD, Stanley MA: Diazepam reinforcement in anxious patients. Experimental and Clinical Psychopharmacology 4(3): 308-314, 1996.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety
- ClinicalTrials.gov ID
- NCT00004373
- Acronym / sponsor ID
- 199/11960
- Conditions
- Anxiety Disorder, Panic Disorder
- Keywords
- anxiety disorder, disease-related problem/condition, neurologic and psychiatric disorders, panic disorder, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- University of Texas
- Study start
- Mar 1997
- Study completion
- Mar 2001
- First posted
- 19 Oct 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs.
II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence.
III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients.
IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication.
- Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
Detailed description
PROTOCOL OUTLINE: This protocol involves different experiments examining self-medication with anxiolytic medications in selected patients, and cognitive-behavioral therapy for anxiety. Capsules are color coded and taken under double-blind conditions. Compliance is monitored with the Medication Event Monitoring System, which automatically registers the date and time each bottle is opened.
The physician directs therapy administration, using some combination of the following: blind choice test, antianxiety agent(s), placebo, and cognitive-behavioral therapy.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alprazolam | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 9179516Roache JD, Stanley MA, Creson DR, Shah NN, Meisch RA. Alprazolam-reinforced medication use in outpatients with anxiety. Drug Alcohol Depend. 1997 May 2;45(3):143-55. doi: 10.1016/s0376-8716(97)01354-9.
- BackgroundRoache JD, Stanley MA: Diazepam reinforcement in anxious patients. Experimental and Clinical Psychopharmacology 4(3): 308-314, 1996.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John D. Roache study chair
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing alprazolam in people with Anxiety Disorder and Panic Disorder, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00004373, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.