Behavioral Effects for Opioid Use Disorder

(BED(In)(44) Trial)

Overseen By Joshua Lile, Ph.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Joshua A. Lile, Ph.D.

Must be taking: Short-acting opioids

Must not be taking: Buprenorphine, Methadone

Disqualifiers: Respiratory disease, Cardiovascular issues, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 5 sessions

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants do not regularly use other medications, except for hormone-based contraceptives, daily multivitamins, or short-term antibiotics. If you are taking other medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Cue Exposure Therapy for Opioid Use Disorder?

Research shows that cue exposure therapy, which involves exposing individuals to drug-related cues without allowing drug use, can reduce craving in detoxified opiate addicts. Although not all studies show a difference from control groups, some have found significant reductions in craving, suggesting potential benefits in preventing relapse. ^{1 2 3 4 5}

Is cue exposure therapy safe for humans?

The research on cue exposure therapy, used for treating addiction, does not report any specific safety concerns. It has been applied in various settings, including for drug dependence, without noted adverse effects. ^{1 2 3 4 5}

How does cue exposure treatment differ from other treatments for opioid use disorder?

Cue exposure treatment is unique because it focuses on reducing cravings by repeatedly exposing individuals to drug-related cues in a controlled setting, helping them to manage their responses and prevent relapse. This approach is based on the idea that cravings can be conditioned responses to certain cues, and by extinguishing these responses, it may help maintain abstinence. ^{1 2 3 5 6}

What is the purpose of this trial?

The objective of this protocol is to use probabilistic choice tasks, reinforcement learning modeling and fMRI to determine the neurobehavioral mechanisms of decision-making in individuals with opioid use disorder and physical opioid dependence.

Eligibility Criteria

This trial is for individuals aged 18-50 with moderate to severe opioid use disorder, who have used opioids like heroin or fentanyl recently. They must be physically dependent on these drugs, able to speak and read English, and not pregnant if female (effective birth control required). Participants should also be generally healthy with normal oxygen levels.

Inclusion Criteria

I am using effective birth control or am not sexually active.

Able to speak and read English

Otherwise healthy

Exclusion Criteria

I do not have any major health or mental issues that would stop me from following study rules.

I do not have vision or hearing issues that would stop me from completing study tasks.

I have difficult veins for drawing blood or giving IV treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in probabilistic choice tasks, reinforcement learning modeling, and fMRI to study decision-making mechanisms

5 sessions

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Drug Cue
• Money

Trial Overview The study aims to understand decision-making in people with opioid addiction by using tasks that involve choosing between money or drug-related cues while undergoing withdrawal. Brain activity will be monitored through fMRI scans during these tasks.

Participant Groups

Group I: Money-vs-money task Experimental Treatment 1 Intervention

Group II: Drug-vs-money task Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Joshua A. Lile, Ph.D.

Lead Sponsor

Trials

6

Recruited

120+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

In a controlled trial involving 186 subjects with opiate addiction, cue exposure therapy did not significantly reduce relapse rates compared to a control condition, as both groups showed similar reductions in craving and withdrawal symptoms.

Despite undergoing cue exposure treatment, subjects did not exhibit different levels of cue reactivity or relapse at follow-up interviews, suggesting that this method may not be effective in preventing relapse in opiate addiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does post-withdrawal cue exposure improve outcome in opiate addiction? A controlled trial. Dawe, S., Powell, J., Richards, D., et al.[2019]

In a study involving 21 detoxified opiate addicts, both cue exposure and cue exposure with cognitive aversion strategies significantly reduced craving compared to routine treatment alone.

The results suggest that cue exposure can effectively help manage cravings in opiate addicts, and this protocol has been adopted for further clinical trials to explore its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subjective craving for opiates: evaluation of a cue exposure protocol for use with detoxified opiate addicts. Powell, J., Gray, J., Bradley, B.[2019]

Cue exposure therapy is based on the idea that cravings for drugs can be triggered by specific internal and external cues, which can lead to relapse in drug-dependent individuals.

The article emphasizes the need for controlled trials to assess the clinical effectiveness of cue exposure treatment for drug dependence, suggesting that it could be a valuable intervention in addiction therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue exposure in the treatment of drug dependence: the potential of a new method for preventing relapse. Heather, N., Greeley, J.[2006]

In a study involving 127 abstinent heroin-dependent inpatients, cue exposure therapy (CET) led to a significant decrease in physiological reactivity (skin conductance) compared to placebo psychotherapy, indicating some efficacy in reducing physiological responses to drug-related cues.

Contrary to expectations, the CET group experienced higher dropout and relapse rates than the placebo group, suggesting that CET may not be beneficial and could potentially be harmful in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial. Marissen, MA., Franken, IH., Blanken, P., et al.[2022]

Cue exposure techniques are being used more frequently to help treat addictive behaviors by addressing the triggers that lead to cravings and potential relapse.

The effectiveness of these techniques may depend on how well they are combined with skill training and whether they help reduce cravings or change the expectations about drug use outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue exposure and relapse prevention in the treatment of addictive behaviors. Marlatt, GA.[2022]

After 12 months of inpatient treatment, opiate-addicted patients still showed significant cravings and negative emotions when exposed to drug-related stimuli, indicating that addiction cues remain a challenge even after intensive therapy.

A structured cue exposure treatment effectively reduced these cravings and negative feelings, with the benefits lasting for at least 6 weeks after the treatment, suggesting a potential strategy for improving long-term recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cue reactivity and effects of cue exposure in abstinent posttreatment drug users. Franken, IH., de Haan, HA., van der Meer, CW., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Does post-withdrawal cue exposure improve outcome in opiate addiction? A controlled trial. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Subjective craving for opiates: evaluation of a cue exposure protocol for use with detoxified opiate addicts. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Cue exposure in the treatment of drug dependence: the potential of a new method for preventing relapse. [2006]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Cue exposure therapy for the treatment of opiate addiction: results of a randomized controlled clinical trial. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Cue exposure and relapse prevention in the treatment of addictive behaviors. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Cue reactivity and effects of cue exposure in abstinent posttreatment drug users. [2019]