Substance DependencePhase 2NCT01741415
Distress Tolerance Treatment for Substance Users
A Phase 2 study testing SIDI and SC in people with Substance Dependence, run by University of South Florida at 1 site in United States.
Trial summary
Despite recent advances in substance abuse interventions, a large percentage of clients entering residential treatment for substance use will drop out of treatment prematurely, and of the remaining, many will relapse soon after treatment completion. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Dependence
- What is being tested?
- SIDI and SC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2013to 1 Sep 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 years of age
- Not evidencing severe cognitive deficits
- Ability to give informed consent
Who cannot join
- <18 years of age or > 65 years of age
- Not evidencing severe cognitive deficits (site designation of 'not competent to stand trial')
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Agency for Community Treatment Services, Inc
Tarpon Springs, Florida
Christa Trenz-Brower,, MA, christa7@USF.EDU
Marina A Bornovalova, Ph.D.
About this study
Despite recent advances in substance abuse interventions, a large percentage of clients entering residential treatment for substance use will drop out of treatment prematurely, and of the remaining, many will relapse soon after treatment completion. Previous research indicates that an individual's ability to withstand psychological distress is a key factor necessary to maintain drug and alcohol abstinence and to remain in substance use treatment without absconding. In previous work, Dr. Bornovalova developed a specific distress tolerance treatment called Skills for Improving Distress Intolerance (SIDI). This intervention features skills training in behavioral and acceptance strategies and intentional clinical exposure to emotional distress. SIDI was developed and piloted with a sample of urban drug users seeking treatment in a residential facility. Individuals receiving SIDI exhibited greater improvement in distress tolerance than those in two comparison groups (receiving treatment-as-usual and supportive counseling).
Current study. The investigators received NIDA funding to conduct a randomized clinical trial with 325 clients entering a residential substance use treatment facility. Study participants will be randomized into two treatment groups: (1) those receiving SIDI and (2) those receiving Supportive Counseling (SC). Participants will receive 10 treatment sessions over a period of 4 months. Then, the investigators will follow clients for one year to examine treatment retention and abstinence.
- Conditions
- Substance Dependence
- Being tested
- SIDI, SC
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SIDIBehavioural
Also called Skills for improving distress intolerance
SCBehavioural
Also called supportive counseling
| Study group | Role | What they receive |
|---|---|---|
| SIDI | Experimental | Skills for Improving Distress Intolerance treatment protocol: individual, manualized treatment aimed at improving distress intolerance Receives: Behavioral: SIDI |
| SC | Placebo comparator | supportive counseling; psychological placebo/talk therapy - aimed at controlling for non-specific therapeutic factors Receives: Behavioral: SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
abstinence at 1, 3, 6 & 12 month follow-up
Measured via biological verification and timeline follow-back
Measured: 1, 3, 6 month follow-up post-treatment
Secondary outcomes (1)
distress tolerance
ability to tolerate psychological distress
Measured: 1, 3, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2012 (estimated)
- Study start13 May 2013
- Primary completion12 Sep 2018
- Study completion1 Sep 2019 (estimated)
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 Substance DependenceStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01741415
- Sponsor's protocol ID
- R01DA032582
- Status last verified
- May 2017
- First submitted
- 30 Nov 2012
- Last updated
- 11 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Fatimah H, Hunter MD, Bornovalova MA. Modeling the dynamics of addiction relapse via the double-well potential system. J Psychopathol Clin Sci. 2025 Jan;134(1):69-80. doi: 10.1037/abn0000960. Epub 2024 Nov 14.
PubMed 39541537Choate AM, Gorey C, Rappaport LM, Wiernik BM, Bornovalova MA. Alternative model of personality disorders traits predict residential addictions treatment completion. Drug Alcohol Depend. 2021 Nov 1;228:109011. doi: 10.1016/j.drugalcdep.2021.109011. Epub 2021 Sep 1.
PubMed 34521057
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Tolerance Treatment for Substance Users
- ClinicalTrials.gov ID
- NCT01741415
- Acronym / sponsor ID
- R01DA032582
- Conditions
- Substance Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 325 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 13 May 2013
- Primary completion
- 12 Sep 2018 (actual)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 4 Dec 2012 (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.
Despite recent advances in substance abuse interventions, a large percentage of clients entering residential treatment for substance use will drop out of treatment prematurely, and of the remaining, many will relapse soon after treatment completion. Previous research indicates that an individual's ability to withstand psychological distress is a key factor necessary to maintain drug and alcohol abstinence and to remain in substance use treatment without absconding. In previous work, Dr. Bornovalova developed a specific distress tolerance treatment called Skills for Improving Distress Intolerance (SIDI). This intervention features skills training in behavioral and acceptance strategies and intentional clinical exposure to emotional distress. SIDI was developed and piloted with a sample of urban drug users seeking treatment in a residential facility. Individuals receiving SIDI exhibited greater improvement in distress tolerance than those in two comparison groups (receiving treatment-as-usual and supportive counseling).
Current study. The investigators received NIDA funding to conduct a randomized clinical trial with 325 clients entering a residential substance use treatment facility. Study participants will be randomized into two treatment groups: (1) those receiving SIDI and (2) those receiving Supportive Counseling (SC). Participants will receive 10 treatment sessions over a period of 4 months. Then, the investigators will follow clients for one year to examine treatment retention and abstinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SIDI | Experimental | Behavioral: SIDISkills for Improving Distress Intolerance treatment protocol: individual, manualized treatment aimed at improving distress intolerance |
| SC | Placebo comparator | Behavioral: SCsupportive counseling; psychological placebo/talk therapy - aimed at controlling for non-specific therapeutic factors |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years of age
- Not evidencing severe cognitive deficits
- Ability to give informed consent
Key exclusion criteria (3 listed)
- <18 years of age or > 65 years of age
- Not evidencing severe cognitive deficits (site designation of 'not competent to stand trial')
- Unable to give informed consent
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 |
|---|---|---|
| SIDIAlso: Skills for improving distress intolerance | Behavioural | SIDI |
| SCAlso: supportive counseling | Behavioural | SC |
Primary outcome
abstinence at 1, 3, 6 & 12 month follow-up
Time frame: 1, 3, 6 month follow-up post-treatment
Measured via biological verification and timeline follow-back
1 secondary outcome
distress tolerance
Time frame: 1, 3, 6 month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2018.
- Derived from this study: PubMed 39541537Fatimah H, Hunter MD, Bornovalova MA. Modeling the dynamics of addiction relapse via the double-well potential system. J Psychopathol Clin Sci. 2025 Jan;134(1):69-80. doi: 10.1037/abn0000960. Epub 2024 Nov 14.
- Derived from this study: PubMed 34521057Choate AM, Gorey C, Rappaport LM, Wiernik BM, Bornovalova MA. Alternative model of personality disorders traits predict residential addictions treatment completion. Drug Alcohol Depend. 2021 Nov 1;228:109011. doi: 10.1016/j.drugalcdep.2021.109011. Epub 2021 Sep 1.
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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.
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 SIDI and SC in people with Substance Dependence, run by University of South Florida 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Oct 2018. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kelly Lane, BA (813-974-9030, kellylane@mail.usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
abstinence at 1, 3, 6 & 12 month follow-up (time frame: 1, 3, 6 month follow-up post-treatment). 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 NCT01741415, 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 11 Oct 2018.