AlcoholismPhase 4NCT00006489

Treatment for Alcoholism and Post-Traumatic Stress Disorder (Naltrexone)

A Phase 4 study testing Cognitive-Behavioral Therapy and Naltrexone in people with Alcoholism and Alcohol Dependence, run by University of Pennsylvania at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder
What is being tested?: Cognitive-Behavioral Therapy and Naltrexone
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 165 participants
Where: 1 siteUnited States
Study dates: Dec 2000to Feb 2011
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meets criteria for alcohol dependence and post-traumatic stress disorder.
Heavy drinking in the past 30 days (an average of more than 12 alcohol drinks per week with at least 1 day of 4 or more drinks).
Successfully complete medical detoxification.
Exhibit clinically significant trauma-related symptoms.
Live in a commutable distance to the University of Pennsylvania and agree to follow-up visits.
Aged between 18 and 65 years old.
Able to provide an informed consent.
Speak and read English.

Who cannot join

Current diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
Evidence of opiate use in the past 30 days.
Significant risk of violence or history of serious violent behavior during the past year.
Continued contact with an intimate partner if assault by the partner is the index trauma.
Changes in dosage or medication for any SSRI treatment in the three months prior to entering the study.
Unstable or serious medical illness.

Show all 10Show fewer

Current severe psychiatric symptom.
Mental retardation or another pervasive developmental disorder.
Use of an investigational medication in the past 30 days.
Pregnant, nursing or not using reliable contraception.

Trial locations and contacts

1 site in 1 country.

United States1 site

Center for Anxiety, University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder

This study will evaluate naltrexone and cognitive-behavioral therapy treatments for alcohol dependence and post-traumatic stress disorder (PTSD). Subjects will be randomly assigned a 6-month treatment of either: 1) naltrexone alone, 2) naltrexone with PTSD psychosocial therapy, 3) a placebo with PTSD psychosocial therapy, or 4) placebo alone. An enhanced medication management intervention will accompany all treatment conditions. Follow-up assessments will be completed at 9 and 12 months after treatment.

Conditions: Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder
Being tested: Cognitive-Behavioral Therapy, Naltrexone, Placebo
Keywords: Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder, Naltrexone, Cognitive Behavior Therapy
Medical subject headings: Alcoholism, Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive-Behavioral TherapyBehavioural
Twelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week
NaltrexoneDrug
Daily dosing 100 mg for 24 weeks
PlaceboDrug
Pill Placebo daily dosing 24 weeks

Study groups in NCT00006489
Study group	Role	What they receive
Naltrexone alone	Active comparator	Naltrexone alone Receives: Drug: Naltrexone
Naltrexone with CBT for PTSD	Active comparator	Naltrexone with CBT for PTSD Receives: Behavioral: Cognitive-Behavioral Therapy; Drug: Naltrexone
Placebo with CBT for PTSD	Active comparator	Placebo with CBT for PTSD Receives: Behavioral: Cognitive-Behavioral Therapy
Placebo alone	Placebo comparator	Placebo alone Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Measured: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
Drinking Timeline Follow-back Interview (TFBI)
The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.
Measured: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

Secondary outcomes (1)

Penn Alcohol Cravings Scale
The Penn Alcohol Craving Scale is a 5-item self-report measure. It assesses alcohol craving during the prior week. Total scores on this measure range from 0 to 30, with higher scores indicating a higher level of craving.
Measured: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2000Feb 2011

First posted9 Nov 2000 (estimated)
Study startDec 2000
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for AlcoholismStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 165 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00006489
Sponsor's protocol ID: NIAAAFOA12428
Other IDs: R01AA012428, NIH grant R01-AA-012428
Status last verified: Mar 2017
First submitted: 8 Nov 2000
Last updated: 21 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zang Y, Yu J, Chazin D, Asnaani A, Zandberg LJ, Foa EB. Changes in coping behavior in a randomized controlled trial of concurrent treatment for PTSD and alcohol dependence. Behav Res Ther. 2017 Mar;90:9-15. doi: 10.1016/j.brat.2016.11.013. Epub 2016 Nov 24.
PubMed 27930926
Kaczkurkin AN, Asnaani A, Alpert E, Foa EB. The impact of treatment condition and the lagged effects of PTSD symptom severity and alcohol use on changes in alcohol craving. Behav Res Ther. 2016 Apr;79:7-14. doi: 10.1016/j.brat.2016.02.001. Epub 2016 Feb 15.
PubMed 26905901
Foa EB, Yusko DA, McLean CP, Suvak MK, Bux DA Jr, Oslin D, O'Brien CP, Imms P, Riggs DS, Volpicelli J. Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial. JAMA. 2013 Aug 7;310(5):488-95. doi: 10.1001/jama.2013.8268.
PubMed 23925619
Powers MB, Gillihan SJ, Rosenfield D, Jerud AB, Foa EB. Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. J Anxiety Disord. 2012 Jun;26(5):617-23. doi: 10.1016/j.janxdis.2012.02.013. Epub 2012 Mar 3.
PubMed 22480715

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcoholism trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Naltrexone and Cognitive-Behavioral Therapy for Patients With Alcoholism and Post-Traumatic Stress Disorder
ClinicalTrials.gov ID: NCT00006489
Acronym / sponsor ID: NIAAAFOA12428
Conditions: Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder
Keywords: Alcoholism, Alcohol Dependence, Post-Traumatic Stress Disorder, Naltrexone, Cognitive Behavior Therapy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 165 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Dec 2000
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 9 Nov 2000 (estimated)
Results: Posted 21 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Naltrexone alone	Active comparator	Drug: NaltrexoneNaltrexone alone
Naltrexone with CBT for PTSD	Active comparator	Behavioral: Cognitive-Behavioral Therapy, Drug: NaltrexoneNaltrexone with CBT for PTSD
Placebo with CBT for PTSD	Active comparator	Behavioral: Cognitive-Behavioral TherapyPlacebo with CBT for PTSD
Placebo alone	Placebo comparator	Drug: PlaceboPlacebo alone

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Meets criteria for alcohol dependence and post-traumatic stress disorder.
Heavy drinking in the past 30 days (an average of more than 12 alcohol drinks per week with at least 1 day of 4 or more drinks).
Successfully complete medical detoxification.
Exhibit clinically significant trauma-related symptoms.
Live in a commutable distance to the University of Pennsylvania and agree to follow-up visits.

Key exclusion criteria (10 listed)

Current diagnosis of any substance dependence other than alcohol, nicotine, or cannabis.
Evidence of opiate use in the past 30 days.
Significant risk of violence or history of serious violent behavior during the past year.
Continued contact with an intimate partner if assault by the partner is the index trauma.
Changes in dosage or medication for any SSRI treatment in the three months prior to entering the study.

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
Cognitive-Behavioral TherapyTwelve weekly 90-minute individual therapy sessions followed by (6) 90-minute sessions every other week	Behavioural	Naltrexone with CBT for PTSD, Placebo with CBT for PTSD
NaltrexoneDaily dosing 100 mg for 24 weeks	Drug	Naltrexone alone, Naltrexone with CBT for PTSD
PlaceboPill Placebo daily dosing 24 weeks	Drug	Placebo alone

Primary outcome

Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)
Time frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
The PSS-I-IV is a clinician-rated interview that evaluates PTSD symptoms on a frequency/severity scale corresponding to the DSM-IV symptom criteria. The measure has a total score range from 0 to 51, with higher scores indicating more severe PTSD symptoms.
Drinking Timeline Follow-back Interview (TFBI)
Time frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)
The TFBI is an interview that utilizes a calendar method to assess when and how much alcohol was consumed by the participant. At Week 0 (Pretreatment), Week 24 (Posttreatment), and Week 52 (Follow-up), alcohol consumed in the past 90 days was assessed. This measure was then used to calculate the percentage of days drinking in the past 90 days at each time point. Higher scores for percentage of days drinking indicate worse drinking outcomes.

1 secondary outcome

Penn Alcohol Cravings Scale
Time frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)

Results and safety

Results posted to the registry on 21 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Naltrexone + Supportive Counseling	42	29
Naltrexone + CBT (Prolonged Exposure Therapy)	40	26
Placebo + CBT (Prolonged Exposure Therapy)	40	25
Placebo + Supportive Counseling	43	32

Primary outcome: Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV)

Time frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up). Mean (95% Confidence Interval). Unit: units on a scale

Measure	Naltrexone + Supportive Counseling n = 42	Naltrexone + CBT (Prolonged Exposure Therapy) n = 40	Placebo + CBT (Prolonged Exposure Therapy) n = 40	Placebo + Supportive Counseling n = 43
Pretreatment (Week 0)	27.1 (24.7 to 30.8)	30.3 (27.7 to 32.9)	27.7 (24.7 to 30.8)	27.5 (25.4 to 29.6)
Posttreatmwent (Week 24)	15.3 (12.2 to 18.3)	12.2 (8.2 to 16.1)	13.3 (9.3 to 17.3)	15.5 (12.4 to 18.6)
Follow-up (Week 52)	10.9 (7.2 to 14.6)	7.9 (4.1 to 11.8)	10.8 (6.3 to 15.2)	11.1 (8.2 to 14.1)

Primary outcome: Drinking Timeline Follow-back Interview (TFBI)

Time frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up). Mean (95% Confidence Interval). Unit: percentage of days

Measure	Naltrexone + Supportive Counseling n = 42	Naltrexone + CBT (Prolonged Exposure Therapy) n = 40	Placebo + CBT (Prolonged Exposure Therapy) n = 40	Placebo + Supportive Counseling n = 43
Pretreatment (Week 0)	75.4 (67.1 to 83.5)	71.2 (62.5 to 79.9)	78.6 (71.4 to 85.6)	74.1 (66.4 to 81.8)
Posttreatmwent (Week 24)	3.5 (0.1 to 6.8)	7.3 (1.9 to 12.7)	13.4 (5.5 to 21.1)	13.2 (7.3 to 19.2)
Follow-up (Week 52)	21.5 (10.6 to 32.4)	8.8 (3.3 to 14.3)	18.9 (8.8 to 29.1)	27.3 (14.7 to 40.0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected throughout time of participant enrollment and involvement in the study. Participant enrollment began on February 8, 2001 and ended on June 25, 2009. Data collection was completed on August 12, 2010. Therefore, adverse event data were collected for 9 years, 6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naltrexone + Supportive Counseling	3 of 42 (7.1%)	21 of 42 (50%)	Not reported
Naltrexone + CBT (Prolonged Exposure Therapy)	2 of 40 (5%)	21 of 40 (52.5%)	Not reported
Placebo + CBT (Prolonged Exposure Therapy)	4 of 40 (10%)	22 of 40 (55%)	Not reported
Placebo + Supportive Counseling	3 of 43 (7%)	18 of 43 (41.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27930926Zang Y, Yu J, Chazin D, Asnaani A, Zandberg LJ, Foa EB. Changes in coping behavior in a randomized controlled trial of concurrent treatment for PTSD and alcohol dependence. Behav Res Ther. 2017 Mar;90:9-15. doi: 10.1016/j.brat.2016.11.013. Epub 2016 Nov 24.
Derived from this study: PubMed 26905901Kaczkurkin AN, Asnaani A, Alpert E, Foa EB. The impact of treatment condition and the lagged effects of PTSD symptom severity and alcohol use on changes in alcohol craving. Behav Res Ther. 2016 Apr;79:7-14. doi: 10.1016/j.brat.2016.02.001. Epub 2016 Feb 15.
Derived from this study: PubMed 23925619Foa EB, Yusko DA, McLean CP, Suvak MK, Bux DA Jr, Oslin D, O'Brien CP, Imms P, Riggs DS, Volpicelli J. Concurrent naltrexone and prolonged exposure therapy for patients with comorbid alcohol dependence and PTSD: a randomized clinical trial. JAMA. 2013 Aug 7;310(5):488-95. doi: 10.1001/jama.2013.8268.
Derived from this study: PubMed 22480715Powers MB, Gillihan SJ, Rosenfield D, Jerud AB, Foa EB. Reliability and validity of the PDS and PSS-I among participants with PTSD and alcohol dependence. J Anxiety Disord. 2012 Jun;26(5):617-23. doi: 10.1016/j.janxdis.2012.02.013. Epub 2012 Mar 3.

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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.

Edna B. Foa, PhD principal investigator

University of Pennsylvania

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Cognitive-Behavioral Therapy and Naltrexone in people with Alcoholism and Alcohol Dependence, run by University of Pennsylvania 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?

The sponsor lists 8 inclusion and 10 exclusion criteria. 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 21 Apr 2017. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Posttraumatic Stress Disorder (PTSD) Symptom Scale - Interview (PSS-I-IV) (time frame: Week 0 (Pretreatment), Week 24 (Posttreatment), Week 52 (Follow-up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006489, which also lists 4 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 21 Apr 2017.